Pfizer Limited & Anr vs Union Of India & Anr on 1 December, 2016

[Cites 25, Cited by 8]

Delhi High Court

Pfizer Limited & Anr vs Union Of India & Anr on 1 December, 2016

* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Date of decision: 1st December, 2016.
+ W.P.(C) No.2212/2016
PFIZER LIMITED & ANR ..... Petitioners
Versus
UNION OF INDIA & ANR ..... Respondents
AND
453 OTHER PETITIONS AS PER SCHEDULE
Counsels for the petitioners:-
Mr. Kapil Sibal, Mr. P. Chidambaram, Mr. Ashok Desai, Mr. C.S.
Vaidynathan, Mr. Parag P. Tripathi, Mr. S. Ganesh, Mr. A.S.
Chandhiok, Mr. Arvind K. Nigam, Mr. Rajiv Nayar, Mr. Sandeep
Sethi, Mr. Gopal Jain, Mr. Siddharth Luthra, , Mr. Rajiv Virmani, Ms.
Prathiba M. Singh, Mr. Abhinav Vashisht, Mr. Ashwini Mata, Mr.
Suddhanshu Batra, Mr. J.P. Sengh, Mr. Amit Sibal, Mr. Dayan
Krishnan, Ms. Rekha Palli, Senior Advocates.

Assisted By

Mr. Rishi Agrawala, Mr. Rahul Dwarkadas, Mr. Kunal Dwarkadas,
Mr. J. Diwan, Ms. Aayushi Sharma, Ms. Niyati Kohli, Mr. Yuvraj
Chobey, Mrs. Aayushi S. Khazanchi, Mr. Chander M. Lall, Ms. Kripa
Pandit, Mr. Ritesh, Mr. Honey, Mr. Dheeraj Nair, Mr. Manish Jha,
Mr. Mohit Bakshi, Mr. Kunal Mimani, Mr. Kunal Chaturvedi, Mr.
Ankit Choudhary, Mr. Nalin Kohli, Ms. Archana Sahadeva, Mr.
Vivek Ranjan, Ms. Rukma George, Mr. Kapil Midha, Ms. Ruchi
Mahajan, Mr. Praveen Mahajan, Mr. Gaurav Juneja, Ms. Saman
Ahsan, Ms. Anisha Somal, Mr. Akshay Mahajan, Ms. Ankita Patnaik,
Mr. Shruti Munjal, Mr. Ashwin Sapra, Ms. Nattasha Garg, Mr.
Utkarsh Bhatnagar, Ms. Rajeshwari H., Ms. Saman Ahsan, Mr.
Akshay Mahajan, Ms. Neelima Tripathi, Mr. D.D. Majumdar, Mr.
Arunabh Chowdhury, Mr. Vaibhav Tomar, Mr. Karma Dorjee, Mr.
Sangram Singh, Mr. Akshay Saini, Ms. Shruti Choudhry, Mr. Ashish
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 1 of 82
Prasad, Mr. Ashish Virmani, Mr. Avinash Tripathi, Mr. Rohit Sharma,
Ms. Mukta Dutta, Mr. Siddharth Bambha, Mrs. Ayiala Imti, Mr. K.V.
Jagdishvaran, Ms. G. Indira,
Mr. Rajeev K. Panday, Mr. Rajeev M. Roy, Ms. Richa Kapoor, Mr.
Ashish, Ms. Malika Parmar, Ms. Ritika Bhalla Kapur, Mr. Adya
Khanna, Mr. Gaurav Juneja, Ms. Anisha Somal, Ms. Saman Ahsan,
Ms. Niyati Kohli, Ms. Aayushi Sharma, Mr. Akshay Mahajan, Mr.
S.S. Ray, Ms. Manu Monga, Ms. Rakhi Ray, Mr. Vaibhav Gulia, Mr.
Aseem Chaturvedi, Mr. Arvind Kr. Roy, Mr. Vipul Joshi, Ms. Sreya
Aggarwal, Mr. Mohit Kumar, Mr. Ajay Bhargava, Mr. Arvind Kumar
Ray, Mr. Vipul Joshi, Ms. Vanita Bhargav, Mr. Rajiv Bhatnagar, Mr.
Aseem Chaturvedi, Ms. Shreya Agarwal, Mr. Jay Savla, Ms. Shilpi
Chodhary, Mr. Rajpal Singh, Mr. Sanjay Jain, Mr. Akshay Jain, Mr.
Santosh Kumar, Mr. Arjun Singh Bhati,
Mr. R. Jawaharlal, Mr. S. Bawa, Mr. Shyamal Anand, Mr. Abdullah
Hussain, Mr. Rudresh Singh, Mr. Arjun Nihal Singh, Mr. Sanjeev
Singh,
Mr. Vineet Malhotra, Mr. Shubendu Kaushik, Mr. Neeraj Grover, Mr.
Aditya Singh, Mr. Krishnendu Datta, Ms. Sanjana Saddy, Ms. Shruti
Munjal, Mr. Udit Chauhan, Mr. Hemant Daswani, Ms. Gurkamal Hora
Arora, Mr. Binoy Kumar, Mr. Utkarsh, Mr. Anshu, Ms. Kripa Pandit,
Mr. Vikas Mehta, Mr. Rajat Sehgal, Mr. Shivam Singh, Mr. Aditya
Raina, Mr. Rakesh Kumar, Ms. Preeti Kashyap, Mr. Aditya Nayyar,
Mr. Rajiv Bajaj,
Mr. C. Mukund, Mr. S.M. Vivek Anandh, Mr. Vikramjeet, Mr. Ambuj
Kumar, Mr. Kamal Garg, Mr. Manu Bansal, Ms. Amita Singh Kalkal,
Mr. David Rao, Mr. Abid Ali Bereen.P., Ms. Tejaswi Shetty for Mr.
Shyel Trehan, Mr. Siddharth Bambha, Mr. Vineet S. Shrivastava, Ms.
A. Tuli, Mr. Amit Sharma,Mr. Dipesh Sinha, Mr. Rajat Jariwal, Mr.
Akshay Mahajan, Mr. Saman Ashan, Ms. Anisha Somal, Ms. Nayan
Chauhan, Mr. Sumit Rajput, Mr. Alok Kumar & Mr. K.S. Negi, Mr.
S.C. Singhal, Mr. Pradeep Verma, Mr. M.K. Dhingra, Mr. Sushant
Mohapatra, Mr. Aruni Poddar, Mr. Deepak Mohapatra, Mr. Bina
Gupta, Mr. Abhay Anand Jena, Mr. Ranjit Raut, Mr. Sagar Chandra
& Mr. Ankit Rastogi, Mr. Sachin Gupta, Mr. Rohit Gupta, Mr. S.
Patnaik, Ms. Meghna Mishra, Mr. Arjun Mahajan, Mr. Rohan Sharma,
Mr. Pulkit Misra, Mr. Puneet, Mr. Dheeraj, Mr. Ashim Sood, Mr.
Kumar Sislay, Ms. Nayantara Vohra, Mr. Ashim Sood, Ms. Nayantara
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 2 of 82
Vohra, Mr. Rahul Gupta, Mr. Shekhar Gupta, Ms. Ira Gupta, for
applicant in CM No.15846/2016, Mr. Hitesh Saini, Mr. Ankit Mishra,
Mr. Sunil Kumar, Mr. Sandeep Khurana, Mr. Manish Khandelwal,
Mr. Manish Khandelwal, Ms. S.A. Fatima, Mr. R.K. Singla, Ms.
Mallika Parma, Mr. Ashish Negi, Ms. Ritika Bhalla Kapoor, Ms.
Aayushi S. Khazanchi, Ms. Niyati Kohli, Mr. Ravi Shanker Sharma,
Mr. Anup Kumar Kerari, Mr. Vijay Kinger, Mr. Sanjay Verma, Mr.
Rohit Gupta, Mr. Harikrishna Pramod, Ms. Gurmehar S. Sistani,
Counsels for the respondents:-
Mr. Sanjay Jain, ASG with Mr. Amit Mahajan, CGSC, Mr. Kirtiman
Singh, CGSC, Mr. Sanjeev Narula, CGSC, Mr. Anurag Ahluwalia,
CGSC, Mr. Prashant Ghai, Mr. Ripudaman Bhardwaj, CGSC, Mr.
Rishikant Singh, Mr. Waize Ali Noor, Mr. Gyanesh Bhardwaj, Mr.
Sumit Mishra, Ms. Shreya Sinha, Ms. Natasha Thakur, GP, Mr. Rajul
Jain,GP, Mr. Nitya Sharma, Ms. Ruchi Jain, Mr. Rishabh Wadhwa,
GP, Mr. Dev P. Bhardwaj, Mr. Ajay Kalra, Mr. Abhishek Ghai, Mr.
T.P. Singh, Ms. Bani Dikshit, Mr. Vidur Mohan, Ms. Srishti Banerjee,
Ms. Abha Malhotra, Mr. Gaurav Rohilla, Mr. Gaurang Bindra, Ms.
Gunjan Sharma, Advs.for UOI.
Mr. Colin Gonsalves, Sr. Adv. with Ms. Tanya Agarwal, Adv. for
Intervener.
Mr. Manik Dogra, Senior Government Standing Counsel with Mr.
Srikant Misra, GP and Mr. Arpit Shukla, Adv. for UOI.
Ms. Shraddha Bhargava, Adv.
Mr. Pranav Agarwal, Adv. for UOI.
Mr. Bijon Kumar Mishra, Adv.

CORAM:
HON'BLE MR. JUSTICE RAJIV SAHAI ENDLAW

1. These 454 petitions impugn the 344 Notifications dated 10th March,

2016 of the Government of India, all in exercise of power under Section 26A

of the Drugs and Cosmetics Act, 1940 (Drugs Act) in respect of 344 Fixed

Dose Combination (FDC) Drugs and seek to prohibit the respondents Union

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 3 of 82
of India and the Drugs Controller General (India) (Drugs Controller) from

giving effect thereto or from prohibiting the manufacture, distribution and

sale in the territory of India of drugs based on the said FDCs (At one stage of

the hearing the learned ASG appearing for the respondents informed that the

challenge in all these petitions is to 100 odd FDCs only and there is no

challenge to the other of the 344 FDCs subject matter of these Notifications

but it was informed that W.P.(C) No.2500/2016 is preferred by the

Federation of Pharma Enterpreneurs and impugns all the 344 Notifications).

2. W.P.(C) No.2212/2016 impugning Notification No.SO-909 (E) with

respect to FDC of Chlopheniramine Maleate + Codeine Syrup came up

before this Court first on 14th March, 2016 when the counsels for the

respondents appeared on advance notice. Notice of the petition was issued

and in view of the fact that the drug Corex with the said FDC had been

marketed by the petitioner therein for 25 years prior thereto and that the

impugned Notification, save for generally stating that the use of the said drug

was ―likely to involve risk to human beings‖ did not disclose any grave

urgency, the effect of the Notification was stayed and the respondents

restrained from taking any coercive steps against the petitioners or its

stockists / agents pursuant to the said Notification.

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 4 of 82
3. Thereafter, this Court was flooded with other petitions aforesaid. In

all, 458 petitions were received and of which four were withdrawn/disposed

of, either on realising that the drug, which at the time of filing of the petition

was wrongly considered as covered by the Notification was not so covered

or on clarification of the counsels for the respondents of the drug subject

matter of those petitions being not covered by the Notification. Now, 454

petitions aforesaid survive. Though a large number of counsels as listed

above appeared in the petitions but the nature of the challenge being the

same, arguments were addressed with reference to the pleadings in W.P.(C)

No.2212/2016. Needless to state that the same interim order as granted in

W.P.(C) No.2212/2016 followed in other petitions as well. For the sake of

expediency, it was directed that pleadings in all the petitions need not be

completed and that all the petitions will be considered and decided together.

This judgment thus, besides W.P.(C) No.2212/2016, decides the other 453

petitions as well, list whereof is given in Schedule to this judgment.

4. On the request of the learned ASG appearing for the respondents, he

was granted the right of audience first for about one hour on 28 th March,

2016, when hearing began. The counsels for the petitioners were heard on

28th March, 29th March, 30th March & 31st March, 2016. The learned ASG

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 5 of 82
commenced his arguments on 31st March, 2016 and continued on 4th April,

6th April, 18th April, 28th April, 5th May, & 12th May, 2016, on which date,

the counsel appearing for the applicant All India Drug Action Network

seeking impleadment was also heard. The counsels for the petitioners

addressed arguments in rejoinder on 19th May, 2016. On 26th May, 2016,

besides hearing counsels for the petitioners in rejoinder, the counsels for

Veterans' Forum for Transparency in Public Life and one Mr. Dhirendra

Singh, both also seeking intervention, were heard. Arguments of the counsel

for the petitioners continued on 27th May, 30th May, 31st May & 2nd June,

2016, when the learned ASG was also further heard and orders reserved.

5. The Notification impugned in W.P.(C) No.2212/2016 aforesaid is as

under:

"NOTIFICATION
New Delhi, the 10th March, 2016
S.O. 909(E)--Whereas, the Central Government is
satisfied that the use of the drug fixed dose combination of
Chlopheniramine Maleate + Codeine Syrup is likely to
involve risk to human beings whereas safer alternatives to the
said drug are available;
And whereas, the matter has been examined by an Expert
Committee appointed by the Central Government and the
said Expert Committee recommended to the Central

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 6 of 82
Government that the said drug is found to have no
therapeutic justification;
And Whereas on the basis of the recommendations of the
said Expert Committee, the Central Government is satisfied
that it is necessary and expedient in public interest to
regulate by way of prohibition of manufacture for sale, sale
and distribution for human use of the said drug in the
country;
Now, therefore, on the basis of the recommendations of
the said Expert Committee and in exercise of powers
conferred by Section 26A of the Drugs and Cosmetics Act,
1940 (23 of 1940), the Central Government hereby prohibits
the manufacture for sale, sale and distribution for human use
of drug fixed dose combination of Chlopheniramine
Maleate + Codeine Syrup with immediate effect.
[F.No.X-11035/53/2014-DFQC]
K.L. SHARMA, Jt. Secy."
The language of Notifications impugned in other petitions is identical.

6. It is the case of the petitioner in W.P.(C) No.2212/2016:

(i) that Corex is a combination drug sold in India since the year
1989, though its composition has been revised / modified from
time to time with the approval of the Drugs Controller; the
composition was so last changed in 1995;

(ii) that Corex falls under Schedule H-1 of the Drugs and
Cosmetics Rules, 1945 (Drugs Rules) and is sold to end user
only when prescribed by medical practitioners and
administered under their supervision and guidance;

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 7 of 82
(iii) that similar pharmacological composition is being sold in
United States of America (USA), Europe, United Kingdom
(UK) and Australia;

(iv) that Corex is a combination of (1) Chlorpheniramine Maleate
IP; (2) Codeine Phosphate IP; and (3) Carmoisine and Sunset
Yellow CPF as colorants;

(v) that the presence of Chlorpheniramine Maleate in the subject
drug is necessary since it is an antihistamine for relieving
histamine-induced allergic edema or respiratory mucosa;

(vi) that the presence of codeine phosphate in the subject drug is
necessary since it is an antitussive;

(vii) that the manufacture of Corex without either of the ingredients
would be meaningless as it would lose its efficacy;

(viii) that Chlorpheniramine Maleate prevents the nasal and
bronchial secretions which would irritate the glands in the
throat thereby leading to dry cough;

(ix) that codeine phosphate suppresses the glands i.e. reduces the
cough reflexes;

(x) that the combination works effectively as both the ingredients
compliment each other; without the secretions being prevented,
it would be difficult to suppress the cough reflexes and vice-
versa;

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 8 of 82
(xi) that the packaging of Corex contains warning in bold to the
effect that it is to be sold by retail on prescription of registered
medical practitioner and that it is dangerous to consume the
same except under medical supervision;

(xii) that no show cause notice or notice of any other nature was
issued to the petitioner prior to the impugned Notification and
no opportunity of hearing was given;

(xiii) that though the impugned Notification claims that ―safer
alternatives are available‖ but whether the same are efficacious
or not, requires consultation and debate; moreover, no such
alternatives have been disclosed in the Notification;

(xiv) that even if safer alternatives are available, reasonable time
frame is required to adopt the same;

(xv) that such immediate ban on Corex and other similar
combinations which had been in market for over 25 years is
illegal;

(xvi) that the Notification does not refer to any scientifically proven
evidence with regard to the risk to human beings caused by
combination / subject drug Corex;

(xvii) that the procedure prescribed in the Drugs Act and the Drugs
Rules has not been followed;

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 9 of 82
(xviii) that the respondents have acted on the ex-parte findings of the
Expert Committee constituted without any reasonable
justification;

(xix) that all the 344 Notifications issued on the same day have the
same language, showing a complete non-application of mind;

(xx) that no scientific evidence to disprove the therapeutic
justification of any of the ingredients of the drug Corex has
been cited.

7. A counter affidavit dated 19th March, 2016 was filed by the Deputy

Secretary to the Government of India pleading:

(a) that a list of Fixed Dose Combinations (FDCs) as approved by
the Ministry of Health and Family Welfare, Government of India
(Ministry) was published on the website of Central Drugs
Standard Control Organisation (CDSCO) in the year 2013 in
which the FDC of Chlorpheniramine Maleate + Codeine Syrup
manufactured by the petitioner was not mentioned as an approved
drug;

(b) that the aforesaid list was appended with a footnote mentioning
that if any inconsistency is observed, the same may be brought to
the notice of the Drugs Controller for necessary action;

(c) that the petitioner never disclosed that it holds some kind of ‗No
Objection Certificate' (NOC) from the Drugs Controller for this
combination;
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 10 of 82
(d) that the petitioner had never formally approached CDSCO
apprising of the status of its approval;

(e) that it came to the knowledge of CDSCO through National
Pharmaceutical Pricing Authority (NPPA) in some other matter
that the product Corex is having some NOC dated 10th March,
1995 from the Drugs Controller; accordingly the status of
approval was uploaded on the CDSCO website on 7th May, 2015;

(f) that the Drugs Act had been enacted with the objective of
assuring the rationality, safety and efficacy of drugs marketed in
the country with a view to protect public health;

(g) that the combination of two or more drugs i.e. FDC, for the first
time fell under the definition of a ‗new drug';

(h) that the requirements for import, manufacture of new drug
including FDCs was introduced in Drugs Rules with effect from
21st September, 1988 by introducing Rules 122A, 122B, 122D &
122E and Schedule Y which required that the manufacturers of
FDCs falling under the definition of new drug shall require the
permission from Drugs Controller;

(i) that FDC is a new drug as defined under Rule 122E which
specifies the procedure to be followed for obtaining
manufacturing permission / marketing authorisation;

(j) that the said procedure involves examination and experimentation
including clinical and non-clinical studies of the molecule and the

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 11 of 82
applicant is required to establish the rationality, safety and
efficacy of the FDC;

(k) that the Competent Authority for the grant of approval for import,
manufacturing and marketing of any new drug in the country is
the Licensing Authority as defined in Rule 21(b) of the Drugs
Rules, i.e. the Drugs Controller;

(l) that a product which falls under the definition of a new drug but
is wrongly licensed by any State Licensing Authority (SLA)
without any approval of the Drugs Controller cannot be the basis
to assume that the product is rational, safe and efficacious;

(m) that the permission from the Drugs Controller is pre-requisite
before new drug is licensed by the SLA for manufacture for sale
or sale in the country;

(n) that however the manufacturers, from September, 1988 till 1st
October, 2012, were obtaining the licenses for manufacturing
such FDCs which fall under the ambit of new drug, without due
approval of the Drugs Controller;

(o) that in order to address this issue, the Ministry had issued
repeated statutory directions under Section 33P of the Drugs Act
to the State Governments to instruct their respective Drug
Licensing Authorities to refrain from granting licences for
manufacture of new drugs and FDCs covered under the definition
of new drug without the approval of the Drugs Controller;

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 12 of 82
(p) that the last such direction was issued on 1st October, 2012;

(q) that the practice of obtaining licences from SLAs for FDCs which
had never been evaluated for their safety and efficacy prior to
their licence had continued unabated;

(r) that earlier, in 2007, the Drugs Controller had received
complaints from consumer associations regarding the rationality
of certain FDCs marketed in the country;

(s) that as a part of follow up action on the complaints, the Drugs
Controller prepared a list of 294 FDCs and directions were issued
to the State Drugs Controllers to withdraw 294 FDCs which were
licensed without approval of the Drugs Controller;

(t) that however the manufacturers association obtained a stay from
the Madras High Court and the matter is still sub-judice;

(u) that taking cognizance of the situation, the Parliamentary
Standing Committee on Health and Family Welfare in its 59th
report on the functioning of CDSCO also took notice of the SLAs
having issued manufacturing licences for a large number of FDCs
without prior clearance from CDSCO and resulting in the
availability of many FDCs in the market which had not been
tested for safety and efficacy, putting patients at risk;

(v) that the Parliamentary Standing Committee also observed that
Section 26A of the Drugs Act is adequate to deal with the
problem of FDCs not cleared by CDSCO;

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 13 of 82
(w) that pursuant to the aforesaid report, the Ministry issued
directions aforesaid on 1st October, 2012 followed by letters dated
15th, January 2013 and 5th July, 2013 to the State Drugs
Controllers to ask the manufacturers to make their applications to
the Drugs Controller;

(x) that in response thereto, CDSCO received a large number of
applications from the manufacturers;

(y) that with the approval of Ministry, CDSCO, on 3rd February,
2014, constituted ten different committees for examination of the
said applications received by it;

(z) that the meetings of those committees took place on various dates
and discussed the FDCs;

(aa) that the said ten committees examined only limited number of
applications out of the large number received;

(bb) that therefore in public interest, in order to examine the remaining
applications in a timely manner, the Ministry vide order dated
16th September, 2014 constituted a committee under the
Chairmanship of Professor C.K. Kokate, Vice-Chancellor, KLE
University, Belgaum, Karnataka for examining the safety and
efficacy ―of these FDCs‖;'

(cc) that the terms of reference of the Kokate Committee were as
under:

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 14 of 82
"a. Those FDCs which are considered grossly
irrational/unsafe based on pharmacokinetic and
pharmacodynamic interation, dosage compatibilities of
FDCs vis-a-vis that of single ingredients present in the
FDC and available literature/evidence.
b. Those FDCs which the Committee may consider
necessary for further deliberation with any of the 10
Expert Committees already constituted.
c. Those FDCs which are considered as safe and
effective based on pharmacokinetic and
pharmacodynamic interation, dosage compatibilities of
FDCs vis-a-vis that of single ingredients present in the
FDC, available literature/evidence, clinical experience
and other data available.
d. Those FDCs which may be considered as rational,
based on present data and knowledge available.
However, data in post market scenario is required to be
generated within a period of 1 to 2 years to confirm the
same."
(dd) that series of meetings were conducted by the Kokate
Committee for examination of these FDCs;

(ee) that the first assessment report of the Kokate Committee was
submitted to the Ministry on 19th January, 2014 and on
examination whereof the Ministry requested the Kokate
Committee to make detailed presentation;

(ff) that accordingly, the Chairman of the Kokate Committee along
with the members presented the report before the Ministry on 4 th
March, 2015, when the Kokate Committee was requested to
further examine and elaborate the scientific reasons for each

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 15 of 82
FDC considered as irrational by the Kokate Committee and
submit report;

(gg) that further meetings of Kokate Committee took place on 7 th
April, 2015 and 8th April, 2015 and detailed report specifically
in this regard was submitted to the Ministry on 16th April, 2015;

(hh) that the Government, after examination of the matter, accepted
the recommendations of Kokate Committee and based on those
recommendations, in case of FDCs declared as irrational, it was
decided to issue show cause notices and give opportunity ―to the
applicants, who had applied for such FDCs to CDSCO‖;

(ii) that accordingly, show cause notices were issued and a period of
thirty days was given to respond and which was subsequently
extended by ninety days;

(jj) that the replies received were examined by the Kokate
Committee and further recommendations were given by the
Kokate Committee on 10th February, 2016, after thorough
examination of all replies and data with respect to each
composition of FDC;

(kk) that the Kokate Committee also invited one expert of Internal
Medicine in all these meetings and one relevant subject expert
nominated by the Director General Health Services, wherever
necessary;

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 16 of 82
(ll) that the Government had thus made elaborate efforts to ensure
that all facets of the matter got duly examined and no injustice is
done to anyone and that the safety of patients is not
compromised;

(mm) that in the process, sufficient notice and opportunity has been
given to all concerned to present their case;

(nn) that in cases where the composition of the FDC was found
irrational even after second examination including of the replies
from the applicants, the Government had no option but to
prohibit them and hence the impugned Notifications under
Section 26A of the Drugs Act were issued;

(oo) that in compliance with the letter dated 15th January, 2013 supra,
applications were also received in respect of FDC of
Chlorpheniramine Maleate + Codeine Syrup from various
manufacturers except from the petitioner in W.P.(C)
No.2212/2016;

(pp) that even when show cause notices were issued to the applicants
of this very FDC, the petitioner in W.P.(C) No.2212/2016 chose
not to submit any representation to the office of the Drugs
Controller for proving the safety and efficacy of its drug Corex;

(qq) that the petitioner in W.P.(C) No.2212/2016 was in full
knowledge of the fact that the safety and efficacy of this
particular FDC was under examination;

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 17 of 82
(rr) that though Corex has some kind of NOC dated 10 th March,
1995 from the Drugs Controller and for reason whereof the
approval status thereof was uploaded on the website on 7 th May,
2015 but the Kokate Committee examined this FDC in the
context of other applicants who had applied to Drugs Controller
considering this as an unproved FDC;

(ss) that even if an approval to this FDC was granted in the year
1995, it was done on the basis of literature and knowledge
available at that point of time and the same does not bar re-
examining the FDC in the current scenario in the light of latest
scientific knowledge and information and which has been done
by the Kokate Committee which has found the FDC of Corex to
be irrational and recommended its ban for the following reasons:

 "Pharmacodynamically irrelevant and
pharmacokinetic mismatch. Also it has abuse
potential.
 Dosing schedule is incompatible.
 Both the ingredients will aggravate the adverse
effects of sedation and drowsiness and also will
interfere with the reflexes.
 There is a high risk of abuse potential of this
formulation in Indian scenario."

(tt) that Corex Syrup available in India is not approved in USA,
UK, Australia or any other country;

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 18 of 82
(uu) that the combinations referred to by the petitioner are mostly in
‗tablet' form and containing Chlorpheniramine Maleate in sustained
release form and not as plain syrup. Codeine and Chlorpheniramine
Maleate when combined as such in a syrup form makes its dosing
schedule incompatible as codeine has a half life of 2.9 hours, while
half life of Chlorpheniramine Maleate varies from 12 to 43 hours;

(vv) that both these ingredients when mixed together in a syrup form
will aggravate the adverse effects of sedation and drowsiness and also
will interfere with the reflexes which is harmful for children and
geriatric patients;

(ww) that since the petitioner in W.P.(C) No.2212/2016 did not come
out to show that it has NOC from the Drugs Controller, despite having
knowledge that the safety and efficacy of its FDC was being
examined, there was no occasion to issue any notice to the petitioner
and which notice was issued to other applicants;

(xx) that the letter dated 15th January, 2013 supra was put on the
official website of CDSCO giving an opportunity to all the
manufacturers to apply to CDSCO for proving safety and efficacy;

(yy) that the matter was also discussed on 24th July, 2015, at the 48th
meeting of the Drugs Consultative Committee (DCC) constituted
under Section 7 of the Drugs Act and which comprises of members
from all the State Drug Control Departments and DCC recommended
that the ban on manufacture and sale of Phensedyl and preparations

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 19 of 82
having similar composition may be considered by CDSCO in view of
its rampant misuse and illegal export to neighbouring countries;

(zz) that the reference by the petitioner to the use of individual
ingredients present in their drug is misconceived, as the prohibition is
on the combination and not on individual drugs present in the FDC;

(aaa) that there is a pharmacokinetic mismatch in the individual drugs
and which aggravates the adverse effect of sedation and drowsiness
and interferes with the reflexes;

(bbb) that in the Indian scenario, there is also a high risk of abuse
potential;

(ccc) that Section 26A of the Drugs Act, in exercise of power
whereunder the Notifications had been issued does not require the
consultations with the Drugs Technology Advisory Board (DTAB)
constituted under Section 5 of the Drugs Act or with the DCC.

8. The petitioner has filed a rejoinder, pleading:

(i) that from the counter affidavit of the respondents, it stands
admitted:

(a) that the respondents had knowledge that the petitioner
had been granted licence to manufacture and market
Corex as far back as on 10th March, 1995 but inspite
thereof, the respondents did not issue any notice to show
cause or grant an opportunity of hearing to the petitioner;
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 20 of 82
(b) that the list of new drugs including FDCs published on
the website of CDSCO in the year 2013 had admittedly
failed to include Corex therein and which list was
subsequently rectified;

(ii) that as evident from the terms of reference thereof, the Kokate
Committee was constituted for the limited purpose of examining
the FDCs permitted for manufacture and sale in India by various
SLAs without prior approval of Drugs Controller; the scope of
reference of Kokate Committee was targeted at manufacturers
and distributors who were undertaking activities merely on the
basis of SLA approvals, without prior approval from Central
Government; however the petitioner has a licence from the
Drugs Controller to manufacture Corex;

(iii) that the findings of the Kokate Committee thus have no
relevance to Corex;

(iv) that the report of Kokate Committee also does not refer to or
provide any cogent evidence or scientific data whilst arriving at
its recommendation to prohibit manufacture, distribution and
sale of Corex;

(v) that though the impugned Notification prohibited the
manufacture of the combination of Corex on the ground of
therapeutic justification but the recommendations of Kokate
Committee purport to state that the combination of Corex does
not have therapeutic value;
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 21 of 82
(vi) that under Section 26A of the Drugs Act therapeutic
justification is clearly in relation to ingredients and / or the
quantity of ingredients;

(vii) that the report of Kokate Committee fails to consider the
ingredients and / or the quantity of ingredients of Corex;

(viii) that the impugned Notification is inconsistent with the report of
Kokate Committee;

(ix) that the Kokate Committee as per its report analysed 1083 FDCs
within a period of six days from 4th January, 2016 to 9th January,
2016 and suffers from non-application of mind and perversity;

(x) that the report of Kokate Committee though records that those
combinations that had already been approved by the Drugs
Controller had been inadvertently included in the list of drugs
categorised as ‗irrational' and in which Corex is included but
still proceeds to recommend ban on Corex;

(xi) that merely because Corex was not mentioned in the list
published on the website of CDSCO in 2013 does not alter the
fact that the petitioner had obtained the necessary licence for
manufacture and sale of Corex from the Drugs Controller as far
back as in March, 1995;

(xii) that the petitioner was thus entitled to receive a specific show
cause notice and opportunity to be heard before the impugned
Notification;
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 22 of 82
(xiii) that since the petitioner was holding a licence from the Drugs
Controller, there was no need for them to make a fresh
application or to make any representation;

(xiv) that the reliance on the Minutes of the 48th Meeting of DCC is
misplaced as the issues discussed therein do not pertain to
rationality, efficacy and safety of Corex; rather the issues
discussed at the said meeting pertain to rampant misuse and
illegal export of Corex;

(xv) Section 26A does not contemplate misuse and abuse as a ground
for prohibition.

9. The hearing on the first three days i.e. 28th, 29th and 30th March, 2016

revolved around, whether the FDCs subject matter of impugned

Notifications are a ‗new drug' within the meaning of Rule 122A, what was

the status of FDCs which, even though qualified as a ‗new drug' but licence

for manufacture whereof had been granted prior to the incorporation of ‗new

drug' in the Drugs Rules, whether they required approval from the Drugs

Controller, etc. It was inter alia the contention of the learned ASG that of the

344 FDCs which have been banned/prohibited by the impugned

Notifications, only 4 or 5 had the approval of the Drugs Controller. It was

further stated that only 5 or 6 FDCs find mention in the Indian Pharmacopeia

and they are not included in the FDCs which have been banned. Per contra it
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 23 of 82
was the contention of the senior counsels for the petitioners that the FDCs

did not require the approval of the Drugs Controller, being not a ‗new drug'

and manufacturing thereof having been permitted by the Authorities under

the Drugs Act.

10. Finding that the Impugned Notifications were not on the ground of the

petitioners or any of them not having the requisite approval, it was enquired

from the learned ASG, why the said aspect should be gone into in these

petitions when that is not the ground on which the Notifications impugned in

the petitions had been issued.

11. The learned ASG agreed that the hearing can go on without going into

the aspect of approvals and leaving it open to the respondents to, if so desire,

take up the said aspect separately. Accordingly, in the order dated 30th

March, 2016, it was clarified that ―this Court in adjudicating these petitions

or even for the purpose of the interim relief therein is not entering into the

question whether the petitioners have the requisite approval for manufacture

of the FDC drugs qua which Notifications dated 10th March, 2016 have been

issued and will be deciding the validity of the Notifications de hors the said

aspect‖. Earlier, on 28th March, 2016, it had already been clarified that this

Court in these petitions is concerned only with the ban under the impugned
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 24 of 82
Notifications and the interim orders in the petitions will not come in the way

of the respondents taking action under any other provision.

12. Though during the subsequent hearings, inspite of it being so clarified,

the said aspect of approvals kept surfacing but in view of the clarification

issued on 30th March, 2016 I am in this judgment not adjudicating the said

aspect.

13. For inter alia the aforesaid reason, I am in this judgment also not

following my usual style of judgment writing, of recording the submissions

of counsels in detail as the same would unnecessarily burden the judgment,

when all submissions made are not for adjudication.

14. After hearing the senior counsels for the petitioners till 30 th March,

2016, in the order dated 30th March, 2016, it was also recorded as under:

"5. The senior counsel for the petitioner in W.P.(C)
No.2212/2016 has also drawn attention to the letter dated 1st
October, 2012 of the Ministry of Health and Family Welfare,
Government of India to Health Secretaries of all States/Union
Territories directing them not to grant licence for manufacture, for
sale or for distribution of FDC drugs and to order dated 16th
September, 2014 of the Government of India, Ministry of Health
and Family Welfare constituting the Committee under the
Chairmanship of Professor Chandrakant Kokate on whose
recommendation the impugned Notifications have been issued.
6. A perusal of the order dated 16th September, 2014 shows that
the reason and purpose of constitution of the said Committee was:-

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 25 of 82
(a) that the States/Union Territories though not entitled to
grant manufacturing licences for drugs falling under the
definition of „New Drugs‟ had granted such licences
inspite of directives not to grant such licences and the last
of which directives was contained in the letter dated 1st
October,2012 supra.
(b) in respect of licences granted to manufacture FDC drugs
falling under the definition of „New Drugs‟ licensed by
State Licensing Authorities before 1st October, 2012
without permission of DCGI, it was decided that DCGI
would ask all the State Drug Controllers to ask the
concerned manufacturers to prove the safety and efficacy
of such FDCs within a period of 18 months failing which
such FDCs will be considered for being prohibited for
manufacture.
(c) in response thereto applications with respect to many
such FDCs for examination were received.
(d) the Committee was being constituted to examine such a
huge number of applications in a timely manner.
(e) the terms of reference to the Expert Committee were also
to advise DCGI and examine the rationality as well as
safety and efficacy of FDCs which fall under the
definition of „New Drugs‟ and are licenced by State
Licensing Authorities without due approval of DCGI.
7. It would thus appear that the Committee of Professor Kokate
on whose recommendation the impugned Notifications have been
issued was constituted not to consider exercise of power under
Section 26A of the Drugs and Cosmetics Act, 1940 but to
consider whether the licences / approvals sought by existing
manufactures of FDCs with licences from State Authorities, in
pursuance to the directive of the Government of India to also seek
the approval of the DCGI, were to be granted.
8. The senior counsel for the petitioner in W.P.(C)
No.2212/2016 in response to a query informs that such permission
was sought under Rule 122B of the Drugs and Cosmetics Rules,
1945, as for a new drug. He also contends that at least the
petitioner in W.P.(C) No. 2212/2016 has the approval of DCGI
also.
9. I have wondered whether power under Section 26A can be
exercised by the Central Government in pursuance to
recommendations of a Committee constituted to consider
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 26 of 82
applications for approval of a new drug under Rule 122B of the
Drugs and Cosmetics Rules, 1945. Prima facie it appears that
consideration of application under Rule 122B can either result in
grant of approval or rejection of approval. I am informed that
rejection of approval is appealable under Rule 122DC.
10. The power under Rule 122B of approval or disapproval of
new drug has to be exercised by the Licensing Authority i.e. DCGI.
A question also arises whether DCGI can delegate such power to
an external Committee and whether such committee followed the
procedure prescribed to be followed under Rule 122B and if not to
what effect.
11. It is also the contention of senior counsel for the petitioner in
WP(C) No. 2212/2016 that the statutory technical bodies, also
constituted under the Act to perform technical functions under the
Act have not been involved in the decision making process leading
to impugned notifications.
12. It is yet further the contention that though the FDCs have
been in the market for years, if not decades but it was not
considered that there are no complaints with respect thereto.
13. In view of the aforesaid, it is deemed appropriate to, before
hearing the other appearing counsels/senior counsels, the learned
ASG be heard particularly on the aforesaid aspect. I have recorded
my thought process so that the doubts arising in my mind can be
addressed by the learned ASG. A draft of this order be circulated.
14. List for arguments of the learned ASG on 31st March, 2016."

15. The learned ASG, on the next dated i.e. 31st March, 2016 clarified (and as

recorded in the order of that date):-

"9. Learned ASG before commencing his arguments, with
reference to the draft order has clarified i) that his stand was / is
that the petitions be decided on the basic issue pertaining to
decision making process under Section 26A of the Drugs and
Cosmetics Act; nonetheless the question whether the petitioners
have the requisite approvals / licence will have to be gone into to
determine the locus standi of the petitioners to maintain the
petitions inasmuch as no relief can be granted to the petitioners
who do not even have the requisite approvals for manufacture of
the concerned FDC; ii) that para 6 of yesterday‟s order mixes up
between the recitals of the order dated 16th September, 2014 and
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 27 of 82
the terms of reference to the Kokate Committee; iii) that the terms
of reference were wide enough to cover Section 26A; and, iv) that
applications received and which were referred to Kokate
Committee were not under Rule 122B."
16. I am of the view that, merely for the purpose of determining the locus

standi of each petitioner to maintain the respective petition no conclusive finding

in this judgment with respect to the licence if any held by the petitioner in each of

the petitions for manufacturing the FDC with respect to ban whereof vide

Notification under Section 26A the petition is filed, need to be given. Suffice it is

to state that with respect to whichever petition the counsel for the respondents

stated that copy of licence had not been filed with the petition, the counsel therein

made up the deficiency.

17. In response to the query raised on 30th March, 2016 and as recorded in

para 9 of the order of that date and reproduced above, Dr. Sumani, Joint

Drugs Controller General of India, on 18th April, 2016 informed (and as

recorded in the order of that date) that in the issuance of impugned Section

26A Notifications, Drugs Controller was not involved. Vide order dated 12th

May, 2016, the learned ASG was granted opportunity to place on record the

Standard Operation Procedure (SOP) to be followed by Drug Controller in

considering an application under Order 122B. The same was handed over.

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 28 of 82
18. I may in this context also note that having gone through the Drugs

Acts and though finding the preamble thereof providing that the enactment

thereof is to regulate inter alia the manufacture of drugs but not finding any

provision therein to regulate the manufacture of drugs, I, during the hearing

on 4th April, 2016 wondered, in the context of which provisions pleas in the

counter affidavit of the respondents, of the licences having been issued by

the SLAs without the Drugs Controller approving the drugs, were taken.

19 The learned ASG on 6th April, 2016 very frankly admitted that the

Drugs Act when enacted in the year 1940 was concerned primarily with

import of drugs as there were then no manufacturing facilities in India and

thus this lacuna has remained in the same inspite of amendment from time to

time. He in this context also drew attention to the Drugs and Cosmetics

(Amendment) Act, 1982, as per the ‗Statement of objects and reasons'

whereof though the need for amendment arose to impose more stringent

penalties on anti social elements indulging in manufacture or sale of

adulterated, spurious drugs not of standard quality which were likely to

cause death or grievous hurt to the user, but the opportunity was being

availed of to also incorporate provisions on the other aspect of effective

control on the manufacture of drugs to empower the Central Government to

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 29 of 82
prohibit import or manufacture of drug in public interest, where the

Government is satisfied that use of any drug is likely to involve risk to

human beings.

20. I, on 6th April, 2016, suggested to the learned ASG that now that he

himself was stating that the Drugs Act was primarily dealing with the import

of drugs and was not found to have any substantive provision regarding

‗controlling and regulating the manufacture of drugs', to make necessary

recommendations to the Government either for re-enactment or for

amendment thereof. I am happy to note that in the last about one month

there has been news report of a relook being had by the authorities concerned

qua the Drugs Act and the proposal to enact a new law.

21. The senior counsels/counsels for the petitioners made extensive

arguments on the merits of the reasons given by the Kokate Committee for

banning each of the 344 FDCs and which were rebutted by the learned ASG.

However, the need to record the said contentions or to adjudicate the same is

also not felt as I am of the view that the same is beyond the scope of judicial

review.

22. Supreme Court in Vincent Panikurlangara Vs Union Of India

(1987) 2 SCC 165 was concerned with a petition seeking ban on import,
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 30 of 82
manufacture, sale and distribution of such drugs which had been

recommended for banning by the DCC. A prayer in the petition was also

made for cancellation of all licences authorising import, manufacture, sale

and distribution of such drugs. Interestingly, the claim in that petition also

was for withdrawal of 7000 FDCs. It was held that the issues that fell for

consideration were not only relating to technical and specialised matters

relating to therapeutic value, justification and harmful side effect of drugs

but also involved examination of correctness of action taken by the Union

of India and the Drugs Controller on the basis of advice ; the matter also

involved the interest of manufacturers and traders of drugs as also the

interest of patients who require drugs for their treatment. It was further held

that ―having regard to the magnitude, complexity and technical nature of the

enquiry involved in the matter and keeping in view the far reaching

implications of the total ban of certain medicines...................a judicial

proceeding of the nature initiated is not an appropriate one for determination

of such matters‖. It was yet further held that ―the technical aspects which

arise for consideration in a matter of this type cannot be effectively handled

by a court‖ and that ―no final say in regard to such aspects come under the

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purview of the court‖. Accordingly, the petition was disposed of by issuing

certain directions to the Central Government.

23. Though the judgment aforesaid is more than 25 years old but what was

observed therein holds good today also. It is not as if in the last more than 25

years since the said judgment the Courts have acquired any skill or

developed any mechanism for deciding the questions which the Supreme

Court then held were outside the judicial purview. The same view has been

reiterated in some of the subsequent judgments also mentioned hereunder, in

other context. Thus, I hold that the challenge by the petitioners to the

impugned Notifications on merits thereof does not lie before this Court by

way of a petition under Article 226 of the Constitution of India.

24. Even otherwise, the well settled principles of exercise of power of

judicial review also do not permit this Court to, in exercise of powers under

Article 226 of the Constitution of India, enter into the merits of the decision

taken by the Government. Judicial review has to be of the decision making

process and not of the decision, except within the well defined parameters.

Though the senior counsels for the petitioners particularly the petitioner in

W.P.(C) No.2212/2016 had also contended that the decision on merits also is

capable of being set aside in exercise of powers under Article 226 within the
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 32 of 82
said parameters but the need for that also is not felt for the reasons hereafter

appearing.

25. That takes me back to the queries raised and as recorded in the order

dated 30th March, 2016 the relevant part whereof has been re-produced in

para 14 hereinabove. I now proceed to consider, whether it was incumbent

upon the Government of India to, in exercise of power under Section 26A of

the Drugs Act involve the bodies constituted under the said Act.

26. Section 5 of the Drugs Act mandates the Central Government to

constitute a Board [to be called the Drugs Technical Advisory Board

(DTAB)] ―to advise the Central Government and the State Governments on

technical matters arising out of the administration of this Act and to carry out

the other functions assigned to it by this Act‖. DTAB has been statutorily

prescribed to comprise of (i) the Director General of Health Services; (ii) the

Drugs Controller; (iii) the Director of the Central Drugs Laboratory,

Calcutta; (iv) the Director of the Central Research Institute, Kasauli; (v) the

Director of Indian Veterinary Research Institute, Izatnagar; (vi) the President

of Medical Council of India; (vii) the President of the Pharmacy Council of

India; (viii) the Director of Central Drug Research Institute, Lucknow; (ix)

two persons to be nominated by the Central Government from among
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persons who are in charge of drugs control in the States; (x) one person to be

elected by the Executive Committee of the Pharmacy Council of India, from

among teachers in pharmacy or pharmaceutical chemistry or pharmacognosy

on the staff of an Indian university or a college affiliated thereto; (xi) one

person to be elected by the Executive Committee of the Medical Council of

India, from among teachers in medicine or therapeutics on the staff of an

Indian university or a college affiliated thereto; (xii) one person to be

nominated by the Central Government from the pharmaceutical industry;

(xiii) one pharmacologist to be elected by the Governing Body of the Indian

Council of Medical Research; (xiv) one person to be elected by the Central

Council of the Indian Medical Association; (xv) one person to be elected by

the Council of the Indian Pharmaceutical Association; and, (xvi) two persons

holding the appointment of Government Analyst under the Act and to be

nominated by the Central Government. The term of office of the nominated

and elected members of DTAB has also been prescribed as three years or for

so long as they hold the appointment of the office by virtue of which they are

nominated or elected. DTAB, vide Section 5(4) has been authorised to frame

its bye-laws fixing a quorum and regulating its own procedure and the

conduct of all business and vide sub section (5) to constitute sub-committees

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 34 of 82
for consideration of particular matters. The Central Government has been

mandated vide sub section (7) to appoint a person to be the Secretary of

DTAB and to provide DTAB with clerical and other staff necessary.

27. Section 6 of the Drugs Act mandates the Central Government to

establish a Central Drugs Laboratory under the control of a Director to be

appointed by the Central Government, to carry out the functions entrusted to

it by the Act or by any Rules made thereunder. Section 6 empowers the

Central Government to ―after consultation with‖ DTAB make Rules

prescribing the functions of the Central Drugs Laboratory and the procedure

for analysis or tests of the drugs and for such other matters as may be

necessary.

28. Section 7 mandates the Central Government to constitute an Advisory

Committee to be called the Drugs Consultative Committee (DCC) ―to advise

the Central Government, the State Governments and the Drugs Technical

Advisory Board on any other matter tending to secure uniformity throughout

India in the administration of this Act‖. The DCC has been prescribed to

consist of two representatives nominated by the Central Government and one

representative nominated by each of the State Governments.

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 35 of 82
29. Section 16 requires a drug to comply with the standards set-out in the

Second Schedule to the Act and empowers the Central Government to ―after

consultation with‖ DTAB and after giving notice by notification in the

Official Gazette of not less than three months of its intention, amend the said

Second Schedule.

30. Section 18 prohibits, after such date as may be fixed by the State

Government by notification in the Official Gazette in this behalf,

manufacture or sale of drugs which are not of standard quality except under

and in accordance with the conditions of a license issued for such purpose.

The second proviso thereto however enables the Central Government to,

after consultation with the DTAB, by notification in the Official Gazette,

permit the manufacture or sale of any drug not being of standard quality.

Vide Section 16(1) ―standard quality‖ means the standards set out in the

Second Schedule.

31. Section 26A of the Drugs Act, in exercise of powers whereunder the

Central Government has issued the impugned Notifications, is as under:-

―26A. Power of Central Government to prohibit manufacture, etc.,
of drug and cosmetic in public interest.-- Without prejudice to any
other provision contained in this Chapter, if the Central Government is
satisfied, that the use of any drug or cosmetic is likely to involve any
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 36 of 82
risk to human beings or animals or that any drug does not have the
therapeutic value claimed or purported to be claimed for it or contains
ingredients and in such quantity for which there is no therapeutic
justification and that in the public interest it is necessary or expedient so
to do, then, that Government may, by notification in the Official
Gazette, [regulate, restrict or prohibit] the manufacture, sale or
distribution of such drug or cosmetic.‖

32. The question which arises is, is the Central Government entitled to

exercise the power under Section 26A without consulting or even involving

the DTAB and the DCC. Further question which arises is, whether the

Central Government can exercise the said power in consultation with and on

the advice and recommendation of, another Committee, though also of

technical persons only, constituted by the Central Government.

33. The contention of the senior counsels for the petitioners of course is

that the Central Government cannot so act on technical matters, instead of on

the advice of and in consultation with the statutory bodies aforesaid, in

consultation with and on advice and recommendation of a non-statutory

Committee. It was contended that as per the Report filed by the respondents

in Civil Writ Petition No.698/1993 titled Drug Action Forum Vs. Union of

India in the Supreme Court, the technical sub-Committee of DTAB had

found the guidelines on ingredients of cough mixtures to be in order and

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 37 of 82
which guidelines inter alia provided that FDCs for dry cough to contain a

centrally acting antitussive, either alone or with one or more drugs which

complement its action peripherally by different mechanism along the path of

the cough reflex e.g. (i) antihistanines, (ii) decongestants and (iii)

expectorants. Attention was also invited to the letter dated 10th March, 1995

of the Drugs Controller to the petitioner in W.P.(C) No.2212/2016 conveying

no objection to the marketing of Corex cough syrup with the same

formulation as has been banned today. It was contended that the very fact

that the Drugs Controller had granted approval, implied that there was

therapeutic justification for both ingredients and now the non-statutory

Committee has disagreed therewith, that too without carrying out any tests.

34. Per contra, the learned ASG argued (i) that Section 26A is without

prejudice to any other provision of Chapter IV in which Section 26A is

located and the power thereunder is to be exercised by the Central

Government on its own satisfaction; (ii) that DTAB is not involved in the

grant of approval to any drug and thus cannot have any compulsory role in

prohibition of any drug; (iii) that even DTAB under Section 5(5) is entitled

to include outsiders; (iv) the exercise of powers under Section 26A is only

partially technical but is essentially legislative; (v) there is no mandate to the

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 38 of 82
Central Government in the Drugs Act or the Drugs Rules to, before the

exercise of powers under Section 26A, take advice from DTAB; (vi) the

statute lists the role of DTAB in Sections 6(2), 7(1), 8(2) second proviso to

Section 10, 12(1), 16(2), second proviso to Section 18 and Section 33; on the

contrary there is no such requirement in Section 26A.

35. The learned ASG, on enquiry, as to on what basis he called the

exercise of power under Section 26A to be legislative in nature, stated that

any act of general application is a legislative act and once the act qualifies as

a legislative act, there is no need to provide an opportunity of hearing to

those affected or likely to be affected thereby. It was further contended that

the scope of judicial review qua a legislative act would also be different; the

Court would then not interfere with the satisfaction reached by the authority

vested with the exercise of power. Reliance was placed on:-

(i) Union of India Vs. Cynamide India Pvt. Ltd. (1987) 2
SCC 720 where the Drugs (Price Control) Order, 1979 of
the Central Government in exercise of powers under
Section 3(2)(c) of the Essential Commodities Act, 1955
was held to be a legislative action and it was further held
that legislative action, plenary or subordinate is not
subject to rules of natural justice;

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 39 of 82
(ii) Sitaram Sugar Company Ltd. Vs. Union of India (1990)
3 SCC 223 also laying down that a statutory instrument
such as a rule, order or regulation emanates from the
exercise of delegated legislative power which is part of
the administrative process resembling enactment of law
by the legislature and a party affected by the order has no
right to notice and hearing, unless the statute so requires;

(iii) Prag Ice and Oil Mills Vs. Union of India (1978) 3 SCC
459 similarly holding with respect to Mustard Oil (Price
Control) Order 1977 and observing that the Parliament
having entrusted the fixation of prices to the expert
judgment of the Government, it would be wrong for the
Court to examine each and every minute detail pertaining
to the governmental decision and that the Government is
entitled to make pragmatic adjustments;

(iv) State of Punjab Vs. Tehal Singh (2002) 2 SCC 7, in the
context of issuance of Notifications establishing Gram
Sabha areas and constitution of Gram Sabhas in exercise
of powers under the Punjab Panchayati Raj Act, 1994
holding, that a legislative act is the creation and
promulgation of a general rule of conduct without
reference to a particular case and is distinct from an
administrative act of making and issuance of a specific
direction or the application of a general rule to a particular
case in accordance with the requirements of policy and
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further holding that where provisions of a statute provide
for the legislative activity i.e. making of a legislative
instrument or promulgation of general rule of conduct or a
declaration by a notification by the Government that a
certain place or area shall be part of a Gram Sabha and
does not concern the interest of an individual but relates
to public in general, it will qualify as a legislative act.

36. It was further contended that the power of the Central Government

under Section 26A of the Drugs Act entitles the Central Government to even

undo what the Drugs Controller had done and that DTAB is not expert body

and cannot exercise its power as was required. It was yet further contended

that no mala fides have been attributed to the Kokate Committee or to the

decision making process of the Central Government or even for non-

involvement of DTAB.

37. In response to the contention that Kokate Committee was not

constituted to advise on exercise of powers under Section 26A but to

examine the applications for approval of FDCs for which SLAs had granted

licences between September, 1988 and 1st October, 2012, reliance was

placed by the learned ASG on State of U.P. Vs. Hindustan Aluminium

Corporation (1979) 3 SCC 229 to contend that the Government could

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always alter the scope of exercise already begun and it was contended that all

technical requirements have been satisfied.

38. The senior counsels for the petitioners referred to Ramlila Maidan

Incident Vs. Home Secretary, UOI (2012) 5 SCC 1 to contend that when the

statute provides for establishment of expert body, creation of an ad hoc body

and reliance on the information thereof was wrong.

39. I am unable to agree with the contention of the learned ASG that

exercise of power under Section 26A is only partially technical, whether it be

legislative or not. Section 26A does not vest the Central Government with a

carte blanche to regulate, restrict or prohibit the manufacture, sale or

distribution of a drug. The Central Government can exercise power

thereunder only when satisfied that the drug involves risk to the consumers

thereof or does not have any therapeutic value or contains ingredients of

which there is no therapeutic justification ‗and' that in public interest it is

necessary or expedient to regulate, restrict or prohibit that drug. Thus, power

of regulation, restriction or prohibition under Section 26A cannot be

exercised in public interest, for any reason other than the drug posing a risk

to consumers thereof or having no therapeutic value or no therapeutic

justification. This is evident from the use of the word ―and‖ instead of ―or‖.
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There is no reason to, in Section 26A, read ―and‖ as ―or‖. The decision on

the question, whether a drug is risky or does not have therapeutic value or

does not have therapeutic justification cannot be a matter of policy but has to

be based on scientific technical reasons. It is for this reason only that the

Supreme Court in Vincent Panikurlangara supra refused to be drawn into

examining whether the drugs qua which directions were sought were indeed

risky for consumers or had no therapeutic justification or had no therapeutic

value.

40. Though Section 26A starts with the words ―Without prejudice to any

other provision contained in this Chapter‖ but Sections 5, 6 & 7 aforesaid

providing for constitution of DTAB, Central Drugs Laboratory and DCC ―to

advise the Central Government and the State Governments on technical

matters arising out of the administration of this Act and to carry out the other

functions assigned to it by this Act‖ and ― to carry out the functions entrusted

to it by this Act or any Rules made thereunder‖ or ―to advise the Central

Government, the State Governments and DTAB on any other matter tending

to secure uniformity throughout India of this Act‖ are not to be found in

Chapter-IV in which Section 26A has been placed and are placed in Chapter-

II and thus the provisions of Section 26A do not override the provisions of

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Sections 5 to 7 and/or are not without prejudice thereto, as was suggested by

the learned ASG. Moreover, the words ‗without prejudice to any other

provision' do not negate the other provisions but rather signify that provision

which is preceded by these words is in addition to the other provisions. As

far back as in King-Emperor Vs. Sibnath Banerji AIR 1945 PC 156 and

approved in Shiv Kirpal Singh Vs. V.V. Giri (1970) 2 SCC 567 it was held

that when this expression is used, anything contained in the provision

following this expression is not intended to cut down the generality of the

meaning of the preceding provision. Supreme Court, in Commissioner of

Income Tax Vs. Eli Lilly Company (India) Private Ltd. (2009) 15 SCC 1, in

the context of Section 201(1) and Section 201(1A) of the Income Tax Act,

1961 also held that such words mean that the provisions of both the sub-

sections are to be considered independently without affecting the rights

mentioned in either of the sub-sections.

41. Chapter-IV of the Drugs Act in which Section 26A is placed contains

Section 16 regarding standards of quality and power of the Central

Government as aforesaid to amend the same with three months notice,

Sections 17, 17A, 17B regarding Misbranded Drugs, Adulterated Drugs and

Spurious Drugs respectively, Section 18 containing prohibition of

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manufacture and sale of certain Drugs by the State Governments and the

Central Government and Sections 18 to 26 providing for machinery for

enforcement of standards of quality. Section 26B to Section 33A, also in

Chapter-IV provide for regulation by Central Government of manufacture of

Drugs in public interest and penalties for contravention. Thus, when Section

26A uses the words ―Without prejudice to any other provision contained in

this Chapter‖, all that the same means is that conferment of power on Central

Government under Section 26A does not have the effect of depriving the

Central Government from expressing other powers under other Schemes in

the same Chapter of the Act. A drug can thus cease to be of standard quality

resulting in the manufacture thereof being prohibited, if the standard

prescribed is amended by the Central Government. However the same does

not prevent the Central Government from prohibiting manufacture thereof

under Section 26A if provisions thereof are also satisfied. All that the words

―Without prejudice to any other provision in the Chapter‖ mean is that

powers under each Section of Chapter-IV is independent of each other. Thus

no benefit can be drawn by the respondents from the use of the said words.

42. Though undoubtedly Section 26A does not require the satisfaction

thereunder of the Central Government to be in consultation with or on the

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aid, advice or recommendation of DTAB and/or DCC or after having the

requisite tests carried out from the Central Drugs Laboratory but a mere

absence of the said words from Section 26A would not mean that Section

26A is to be read in isolation. Realising that the functions to be performed by

the Central and the State Governments under the Drugs Act are not

administrative, but largely technical, the Drugs Act has devised the

machinery for advising the Central and the State Governments on such

technical matters arising out of the administration of the Act and to carry out

the functions assigned to them under the Act. Merely because the powers

vested in the Central Government vide some other Sections of the Act

expressly provide for exercise thereof on advice of or in consultation with

DTAB and/or DCC does not take away from the wide language used in

Sections 5&7 while prescribing the purpose of constitution of DTAB &

DCC, to advise the Central Government on technical matters arising out of

administration of the Act and to carry out other functions assigned to Central

Government by the Act. The said words are of general application and it will

be in the domain of DTAB to advise the Central Government in exercise of

all technical powers under the Act, whether the relevant Section prescribes

for the Central Government to before exercising of power thereunder take

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advice of Central Government or not. The need, notwithstanding the

generality of the language of Sections 5&7, to expressly provide for

advice/consultation appears to have been felt to remove any doubt whether in

discharge of power thereunder DTAB/DCC were to be consulted or not. A

statute establishing a body/institution to advise the Central Government in

exercise of powers thereunder ipso facto places a reciprocal obligation on the

Central Government to take the advice of such body/institution. Supreme

Court, as far back as in K.N. Guruswamy Vs. State of Mysore AIR 1954 SC

592 held that once the legislature has deemed it wise not to leave the matter

to the unfettered executive discretion and has enacted law from which a

policy and purpose is evident, the fetters imposed by legislation cannot be

brushed aside at the pleasure of the Government or its officials - The Rules

bind the State and the subject alike. Reference in this regard can also be

made to Ram Singh Vs. Union of India (2015) 4 SCC 697 holding that

though undoubtedly Article 16(4) confers power on the Central Government

to bypass the National Commission for Backward Classes and to include

groups of citizens in the Central List of Other Backward Classes (OBCs) on

the basis of Article 16(4) itself but enactment of the specific statutory

provision constituting a Commission cannot be overlooked. It was further

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held that Central Government cannot be permitted to discard the statutory

norms.

43. Great care has been taken in the Drugs Act to describe the constitution

of DTAB and the DCC. The Drugs Act is a pre-Constitution law made by the

Central Legislature under the Government of India Act, 1935. The subject

matter of the Act, on coming into force of the Constitution of India falls

under Entry 19 List 3 of the Seventh Schedule to the Constitution of India.

Under the said Act the regulation of manufacture, sale and distribution of

drugs is primarily the concern of the State Authorities while the Central

Authorities are responsible for approval of new drugs, clinical trials in the

country, laying down the standards of drugs. It is for this reason that in

DTAB as well as DCC representation of the State Governments has been

provided. Both DTAB and DCC are broad based bodies having

representation also from other statutory institutions and institutions set-up by

the Government and having the knowledge and role to play in the functions

for discharging which DTAB and DCC have been constituted. Though the

Drugs Act does not lay down the procedure for appointment of the Director

of the Central Drugs Laboratory but the very fact that the same has been

provided to be established to carry out functions entrusted to it by the Act or

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the Rules thereunder and by its very name suggests i.e. to carry out the

analysis tests and submit reports on the drugs, it is evident that as to what

will be the criteria for such appointment.

44. The provision in the Drugs Act for constitution of DTAB and DCC as

also in several other statutes for establishment of bodies/institutions for

discharge of powers thereunder, is not without purpose. The reason is to

ensure institutional integrity and compliance of public law principles in

discharge of functions and exercise of power thereunder. Though the

legislature, in the Drugs Act, vested the Central Government with the powers

to be exercised thereunder but at the same time constituted DTAB to advice

the Central Government on technical matters arising out of administration of

the Drugs Act and to carry out other functions assigned to the Central

Government by the Act and the DCC, also to advice the Central Government

and the DTAB on any matter tending to secure uniformity throughout India

in administration of the Act. The role of DTAB thus is not qua technical

matters only but extends to advising the Central Government in carrying out

other functions assigned to it by the Act also. Without such institutions, the

Central Government in the discharge of various functions including of a

technical nature which it is required to discharge under various statutes or its

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Governmental functions would be left with a discretion to choose and

appoint whosoever it may at that point of time desire for advising it on the

matter and which may render the decision of the Central Government open

to challenge on the grounds of bias and competence in the matter of

selection.

45. Even otherwise it defies logic as to why would the Central

Government, when has available to it the machinery provided under the

Drugs Act itself to discharge the functions of a technical nature under

Section 26A, would, instead of using the said machinery choose to follow

another course of action. The only reason which I have been able to gather is

that the constitution of the Kokate Committee does not owe its genesis to

advise the Government in the matter of discharge of functions under Section

26A but for the purposes of scrutinising the applications called for and

received.

46. The respondents, in their counter affidavit have not disclosed any

reason for the Central Government, before issuance of the Notifications

impugned in these petitions, not taking the advice of and consulting DTAB

or DCC or to not have the FDCs which were proposed to be prohibited under

Section 26A tested, examined and analysed by the Central Drugs Laboratory.
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47. Supreme Court in Vincent Panikurlangara supra as aforesaid was

also concerned with a demand in public interest for banning 7000 FDCs on

the ground of the same being injurious to public health. Supreme Court as

aforesaid held that it was beyond judicial review to determine whether the

FDCs of which ban was sought were indeed injurious to public health.

However the Supreme Court found (i) that the Hathi Committee, appointed

by the Central Government in its Report submitted in 1974, highlighted the

havoc played by multinational corporations in Indian scene and pleaded for

nationalising the drug industry in the best interest of the Indian people; (ii)

the said recommendation was not accepted by the Government; (iii) that in

1980, the DCC set up a sub-Committee of experts for screening formulations

of drugs prevalent in the Indian market from the point of therapeutic

rationale in order that irrational and harmful combinations of drugs could be

banned; (iv) the said Sub Committee of experts recommended banning of

twenty FDCs; (v) The sub- Committee's Report was approved by the DCC

as well as the Ministry of Heath in 1981; (vi) the Central Drugs Controller

issued directions to the State Authorities to strictly enforce the ban on drugs

pertaining to these combinations; (vii) however on account of slackness in

the enforcement machinery these drugs were still prevalent in the market;

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(viii) that though the Drugs Act was amended w.e.f. 1st February, 1983 inter

alia to insert Section 26A but owing to interim orders given by the Courts, in

petitions challenging vires thereof, the benefit of the new power conferred on

the Central Government was till then not available; (ix) that the Report of the

sub-Committee aforesaid besides being considered by the DCC was also

considered by the DTAB; (x) though the Court had issued notice to the

Medical Council of India and the Indian Medical Association but both had

failed to respond; (xi) not only a judicial proceeding of the nature initiated

was not an appropriate one for determination of such matters but perhaps the

Hathi Committee too was not one which could be considered as an

authoritative body competent to reach definite conclusions; (xii) no adverse

opinion could therefore be framed against the Central Government for not

acting upon its recommendations; (xiii) the question involved in the matter

was a question of policy; (xiv) no final say in regard to such aspects comes

under the purview of the Court; (xv) what is considered to be the best

medicine today for treatment of a particular disease becomes out of date and

soon goes out of the market with the discovery or invention of new drugs;

(xvi) the problem was likely to arise from time to time; (xvii) the Central

Government on the basis of expert advice can indeed adopt and approve

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national policy; (xviii) it is State's obligation to enforce production of

qualitative drugs and elimination of the injurious ones from the market; (xix)

the process of regulation has to be strengthened; (xx) there is an immediate

need for central enforcement machinery in the interest of community at

large; (xxi) licencing of manufacture should also be centralised so that

uniformity can be maintained; (xxii) Section 5 of the Drugs Act authorises

constitution of a Central Drugs Technical Advisory Board as also a State

Board for each State; (xxiii) the object of setting up of such Boards is to

advise the respective Governments on technical matters arising out of the

administration of the Act; sub-Section (2) provides for the manning of the

Central Board; (xxiv) adequate representation should be provided to

consumers and at least two capable representatives from out of their category

should be nominated by the Central Government; (xxv) the manning of

DTAB should be such as in its functioning it would be in a position to

effectively advise the Central Government on all technical matters;

(xxvi) Section 7 provides for setting up of DCC and its statutory purpose is

to advise the Central Government, the State Governments and the DTAB on

any matter tending to secure uniformity throughout India in the

administration of the Act; (xxvii) in DCC also there should be adequate

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representation on behalf of the consuming public; (xxviii) the Central

Government should set-up regional Drug Laboratories in addition to the

Central Laboratory as provided by Section 6 of the Act; (xxix) though DCC

was existing but Central Government should consider whether it requires to

be broad-based and confined with larger scope of operation the Supreme

Court was not examining the objections raised with reference to specific

medicines as writ was not an appropriate proceeding therefor; and, (xxx)

however the Central Government should take into consideration the

objections and have the same referred to the DCC. Though the Supreme

Court as far back as in Vincent Panikurlangara also held that the matters

such as these should be examined by the DTAB, DCC and Central Drugs

Laboratory constituted under the Drugs Act and that the Report of the Hathi

Committee then constituted was not authoritative but the Government of

India has issued the impugned Notifications dated 10 th March, 2016 on the

recommendations of the Kokate Committee (which is on the same footing as

Hathi Committee) and without consulting either DTAB, DCC or Central

Drugs Laboratory.

48. It was not the contention then of the respondents that DTAB and DCC

were incapable of rendering such services. If it is the case of the respondents

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today that DTAB and DCC as constituted are incapable of rendering the

services as Kokate Committee has rendered to the respondent no.1, then that

shows a serious flaw in the constitution of DTAB and DCC. The contention

thus of the learned ASG that DTAB and DCC were incapable of rendering

such services cannot be accepted.

49. I was in Buddhadev Maity Vs. Union of India

MANU/DE/1035/2010 and against which no appeal is found to have been

preferred concerned with the challenge to the order of the Central

Government in exercise of power under Section 10 of the Contract Labour

(Regulation and Abolition) Act, 1970 deciding not to prohibit employment

of contract labour in normal maintenance, repair or emergency shut down

and operation works in Mechanical Division of Haldia Refinery. Section 3 of

the said Act provides for constitution of a Central Advisory Contract Labour

Board to advise the Central Government on such matters arising out of

administration of that Act as may be referred to it to carry out other functions

assigned to it under the Act. Similarly Section 4 of the Act provides for

constitution of State Advisory Boards and Section 5 for constitution of

Committees by the Central Board and the State Boards. Though Section 10

of the said Act expressly required the Central Government or State

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Governments to after consultation with the Central Board or the State Boards

prohibit employment of contract labour in any process, operation or other

work in any establishment but finding that the impugned order had been

issued without the Board though approached rendering any advice the

petition was allowed. Reliance was placed on (A) Gujarat Working Class

Union Vs. State of Gujarat MANU/GJ/0241/1994 (DB) laying down that

the object of consultation with the Board is not merely to collect information

which the Government could have collected through its own departments or

other agencies; it was held that ―consult‖ implies a conference of two or

more persons or impact of two or more minds to enable them to evolve a

correct solution; it was further held that without any meaningful dialogue

with the Board and interaction of views and thoughts, there was no

consultation of the Government with the Board, which is mandatory;

direction to re-examine the matter in accordance with law was issued; (B)

Indian Airports Employees Union Vs. Air India MANU/MH/0260/1996

(DB) holding that Section 10 (1) imposes a duty on the appropriate

Government to consult the Board and that the advice of the Board has to be

discarded for sound reasons; it was held that the Boards consist of

representative of the workmen, of the industry and appropriate Government

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and so the consultation with these Boards means that the representatives of

the contractor, the workmen and industry will have a voice in expressing

their views when the Board is being consulted with regard to the proposal

whether the contract labour should be prohibited or not; it was further held

that the Act does not vest absolute discretion in the appropriate Government

to prohibit contract labour; matter was remanded for fresh decision; (C) M/s

L & T Mc. Neil Ltd. Vs. Government of Tamil Nadu (2001) 3 SCC 170

laying down that the views of the Board are to be ascertained for the purpose

of assisting the Government in reaching its conclusion on the matter one way

or the other and the Government could not have reached the conclusion one

way or the other in the absence of any advice of the Board; the decision of

the Government in issuing the notification under Section 10(1) was thus held

to be vitiated; and, (D) M/s. Zenith Industrial Services Vs. Union of India

1990 I LLJ 38 (Orr) (DB) also holding that the power under Section 10 has

to be exercised in the manner indicated therein and prior consultation with

the Advisory Board is a must to prevent the Government from misusing or

abusing the power or exercising it arbitrarily. Reference was also made to

Ex-Capt. Harish Uppal Vs. Union of India (2003) 2 SCC 45 holding that no

Body or Authority, statutory or not, vested with powers can abstain from

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exercising the powers when an occasion warranting such exercise arises and

that power vested in a public authority is coupled with a duty to exercise it

when a situation calls for such exercise and the Authority cannot refuse to act

at its will or pleasure and the Courts will always have the authority to compel

or enforce the exercise of the power by the Statutory Authority and will issue

directions as are necessary to compel the Authority to do what they should

have done on their own. Reference was also made to Chandramouleshwar

Prasad Vs. The Patna High Court (1969) 3 SCC 56 holding that

consultation or deliberation is not complete or effective before the authorities

thereto make their respective points of view known to the other and discuss

and examine the relative merits of their views. In Buddhadev Maity it was

held that the whole purpose of constituting a high powered Statutory

Advisory Board would be vitiated if the members appointed thereof do not

get an opportunity to exchange their views with the Government and that

allowing the Government to act without such fair exchange with the statutory

authority would be contrary to the express language and spirit of the Act.

50. What was held by me in Buddhadev Maity supra equally applies here.

The whole purpose of constitution of DTAB, DCC and setting up of Central

Drugs Laboratory would be lost if it were to be held that the Central

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Government, even in exercise of technical powers under Section 26A or in

carrying out other functions assigned to it under the Act is not required to

consult them and is free to choose the person from whom it may at that point

of time take consultation. No such power has been vested under the Drugs

Act with the Central Government.

51. Reference may also be made to the judgment of the Division Bench of

this Court of which the undersigned was a Member in United Rwas Joint

Action Vs. Union of India MANU/DE/3302/2015 (though SLP thereagainst

is pending before the Supreme Court) where, in the context of Section 20 of

the Comptroller and Auditor General's (Duties, Powers and Conditions of

Service) Act, 1971 requiring the terms and conditions of audit to be agreed

upon by the Comptroller and Auditory General (CAG) in consultation with

concerned Government it was held that consultation cannot be namesake and

has to be meaningful and effective. Reliance in this regard was placed on Mr.

Justice Chandrashekaraiah (Retd.) Vs. Janekere C. Krishna (2013) 3 SCC

117 and State of Gujarat Vs. Hon'ble Mr. Justice R.A. Mehta

(Retd.) (2013) 1 SCC 1 holding that (i) the object of consultation is to render

its process meaningful, so that it may serve its intended purpose; (ii)

consultation requires the meeting of minds between the parties that are

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involved in the consultation process, on the basis of material facts and points,

in order to arrive at a correct or at least a statutory solution; and, (iii) if

certain power can be exercised only after consultation, such consultation

must be conscious, effective, meaningful and purposeful; to ensure this, each

party must disclose to the other, all relevant facts for due deliberation and the

consultee must express his opinion only after complete consideration of the

matter on the basis of the relevant facts and quintessence.

52. Once Sections 5&7 of the Drugs Act provide that the purpose of

constitution of DTAB is to advice the Central Government on technical

matters arising out of administration of the Act and to carry out other

functions assigned to the Central Government under the Act and that the

purpose of constitution of the DCC is to advice the Central Government and

the DTAB on any matter tending to secure uniformity throughout India in the

administration of the Act, the other provisions of the Act vesting powers in

the Central Government were not required to expressly provide that the

Central Government will exercise the said power with the advice of and in

consultation with the DTAB and DCC. Whichsoever provision of the Drugs

Act provides for exercise of powers, technical or otherwise by the Central

Government, obtaining advice from and holding consultation with DTAB

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and DCC would axiomatically become mandatory. Moreover the function

prescribed of DTAB in Section 5 is not only to advice on technical matters

but also to carry out ―other functions assigned‖ to the Central Government

under the Act. If the Central Government of its own was found fit to exercise

the functions under the Act including of a technical nature and have the

wherewithal therefor, there was no need for constituting the DTAB and

DCC.

53. Supreme Court in Centre for PIL Vs. Union of India (2011) 4 SCC 1

reiterated that an institution is more important than an individual and an

institution has to satisfy the test of values, independence, impartiality and

competence and so have the persons manning the institution to satisfy the

said tests. If institutions though set-up, particularly those set-up statutorily

are to be bypassed, the same would severally erode the faith in the

functioning of the Central Government and the decisions taken by it under

the law and dent good governance and constitutional trust. Supreme Court in

Manoj Narula Vs. Union of India (2014) 9 SCC 1 held that the principle of

constitutional morality basically means to bow down to the norms of the

Constitution and not to act in a manner which would become violative of the

rule of law or reflectible of action in an arbitrary manner; it actually works at

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the fulcrum and guides as a laser beam in institution building. It was held

that institutional respectability and adoption of precautions for the sustenance

of constitutional values would include reverence for the constitutional

structure. Again in Board of Control for Cricket in India Vs. Cricket

Association of Bihar (2015) 3 SCC 251 it was held that BCCI is a very

important institution that discharges important public functions and demands

of institutional integrity are therefore heavy and need to be met suitably in

larger public interest.

54. All the emphasis laid in the judgments aforesaid on the institutions and

institution building would be futile if the Central Government in exercising

powers under statutes which are prescribed to be exercised on advice and in

consultation with bodies/institutions also set-up under that statute were to be

allowed to exercise those powers without such consultation or in consultation

with other non-statutory bodies. Such statutory/public bodies/institutions

perform public law function and are expected to adhere to those very

standards which the law requires the Government to adhere to, as held by the

Division Bench of this Court in Utkarsh Mandal Vs. Union of India

MANU/DE/3078/2009 in the context of Expert Appraisal Committee under

the Environment (Protection) Act, 1986. It was held that the whole purpose

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of the exercise to be performed by the Expert Appraisal Committee

comprising of Experts was to have a proper evaluation on the basis of

objective criteria.

55. It is not as if powers under Section 26A have been exercised by the

Central Government for the first time. The counsels, during the hearing cited

the following judgments, in all of which the exercise of power was on advice

and in consultation and/or on recommendation of DTAB/DCC:-

(i) Systopic Laboratiries (Pvt.) Ltd. Vs. Dr. Prem Gupta 1994

Supp(1) SCC 160 - the notifications of the year 1983/1988

were preceded by constitution of an expert sub-Committee by

the DCC and recommendations whereof were accepted by the

DCC and considered by the DTAB which recommended the

ban. The representations thereagainst were also examined by the

sub-Committee of DCC whose views were considered by the

DTAB. It was in the aforesaid context that the Supreme Court,

on challenge being made to the ban, expressed its inability to

make an assessment about the relative merits of the various

studies and reports placed before it (as has been done in the

present case also) and held that ―such an evaluation is required
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to be done by the Central Government while exercising its

powers under Section 26A of the Act on the basis of expert

advice and the Act makes provision for obtaining such advice

through the Board and the DCC‖. Finding that the said experts

in their deliberations did not consider it necessary to conduct

clinical trials in respect of FDCs of steroids with

bronchodilators for systematic use it was held that whether

clinical trials should have been conducted or not was primarily

for the experts to decide and if the experts felt that in respect of

the drugs in question such clinical trials were not necessary, it is

not possible to hold that there has been no proper evaluation of

the material that was submitted. The contention that complete

prohibition was disproportionate (as has been made before me

as well) was rejected holding that ―in taking this step the,

Central Government appears to have moved in a cautious

manner‖ in not immediately prohibiting the drug inspite of the

view of the DCC and for the reason of the DTAB having then

not agreed therewith. It was further held that while examining

the reasonableness of the prohibition against manufacture and

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sale of drugs, the harmful potentialities thereof have to be

considered in the context of the conditions as prevalent in the

country and the less drastic course of permitting manufacture

and sale of the drugs with a warning about its use would not be

adequate to protect the general public from the harmful

consequences. The challenge was thus dismissed.

(ii) E. Merck (India) Ltd. Vs. Union of India AIR 2001 Del 326

(DB) - the challenge before the Division Bench of this Court

was to the Notification dated 14th October, 1999 prohibiting

certain FDCs. The impugned Notification was found to have its

origin in Civil Writ Petition No. 698/1993 titled Drug Action

Forum Vs. Union of India before the Supreme Court seeking

action against hazardous drugs. It was found that the Supreme

Court had directed the DTAB to assess the quality and nature of

the of the drugs and that DTAB had constituted a technical sub-

Committee for the said purpose; subsequently Supreme Court

constituted a Core Group, five out of six members of which

were members of DTAB and the Core Group had recommended

the prohibition; the said recommendation was considered by the

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 65 of 82
DTAB which also recommended prohibition; thereafter the

matter was considered by the Government and the impugned

Notification issued. Dismissing the challenge it was held:-

(A) there was no merit it in the challenged to the vires of

Section 26A;

(B) before imposition of such ban the following ingredients

have to be satisfied:-

(i) satisfaction of the Central Government;

(ii) satisfaction has to relate to:-

(a) likely to involve risk to humans; or

(b) it does not have a therapeutic value; or

for which there is no therapeutic

justification; and

(iii) it is necessary or expedient in public interest.

the Central Government is neither uncontrolled nor

unguided;

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 66 of 82
(D) a particular drug would be banned only if the Government

is satisfied about its hazardous nature or nil therapeutic

value, or nil therapeutic justification;

(E) above all, the Government is also to be satisfied that

public interest warrants such prohibition;

(F) all these factors constitute definite guidelines to the

Central Government before it acts to issue the

Notification under Section 26A of the Act of prohibition;

(G) for such a provision to sustain it is not necessary that

statutory appeal has to be provided - even in the absence

of statutory appeal the aggrieved person has the

constitutional remedy;

(H) the Scheme of the Drugs Act further provides for

constitution of DTAB, Central Drugs Laboratory and

DCC for the purpose of carrying out the functions

assigned to it by the Act;

(I) before the Central Government records its satisfaction to

prohibit the manufacture a particular drug, opinion of the

DTAB and/or DCC is obtained;

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 67 of 82
(J) whenever decision of the Central Government taken

under Section 26A of the Act is challenged, while

exercising the power of judicial review the Court can go

into the question as to whether the satisfaction was based

on material, which was relevant and germane to the issue

and that it was not an arbitrary exercise of power;

(K) that since the exercise undertaken was pursuant to

direction issued by the Supreme Court no hearing was

required to be given and the petitioners had submitted

their material before the DTAB;

(L) there was thus sufficient compliance of the principles of

natural justice;

(M) the Government was not under any obligation to issue

show cause notice before issuance of impugned

Notification;

(N) there was no merit in the contention that the impugned

Notification was without any material on record as there

was voluminous material before the sub-Committee of

DTAB and before the Core Committee; and,

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 68 of 82
(O) the Court cannot sit in appeal against the decision of the

Central Government and judicial review of such decision

is available on limited grounds.

(iii) Uni-San Pharmaceuticals Vs. Union of India AIR 2002 Ker

72 - the challenge was to the Notification under Section 26A

prohibiting manufacture, sale and distribution of fixed dose

combination of Hydroxyquinoline group of drugs with any

other drug inter alia on the ground that there was no

consultation with the DTAB. Finding that the Notification was

issued after a thorough examination by a technical sub-

Committee constituted by the DTAB and on the basis of

recommendation made by the DCC and with the approval of

DTAB, the challenge was dismissed.

(iv) Drug Controller General of India Vs. West Bengal Small

Scale Manufacturers Association AIR 2000 Cal 133 (DB) -

Notification dated 13th December, 1995 under Section 26A was

under challenge. Finding that before issuing the Notification the

Drug Controller General of India referred the matter before the

technical sub-Committee of DTAB which was held to be a

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 69 of 82
Statutory Body to advise the Central Government on the

implementation of the Act and that the recommendations of the

sub-Committee were accepted by the Central Government, the

challenge was dismissed.

(v) Cipla Ltd. Vs. Union of India (2011) 5 CTC 640 adjudicating

the challenge to the Notification dated 10th February, 2011

prohibiting manufacture and sale of phenylpropanolamine and

holding that consultation with DTAB is mandatory.

(vi) Social Jurist, A Lawyers Group Vs. Union Of India (2004) 73

DRJ 578 (DB) also holding that consultation with DTAB is

mandatory.

56. It would thus be seen that the challenge to the vires of Section 26A

was rejected in E. Merck (India) Ltd. supra inter alia for the reason of the

Act providing for exercise of power by the Central Government after

obtaining the opinion of DTAB and DCC and the challenge to the

Notifications earlier issued under Section 26A defeated inter alia for the

reason of the same being on recommendation of DTAB and/or DCC.

Certainly the Central Government after having the challenge to the vires of

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 70 of 82
Section 26A on the ground of the same vesting uncontrolled and unguided

discretion in the Central Government for reasons aforesaid, bypass DTAB

and DCC in exercise of power thereunder. Though the learned ASG relied on

the judgment of a Single Judge of the High Court of Madras in Macleods

Pharmaceuticals Limited Vs. Union of India (2012) SCC OnLine Madras

1735 and on judgment of a Single Judge of the High Court of Karnataka in

Lundbeck India Private Limited Vs. Union of India (2013) SCC OnLine

Kar 6622 holding such consultation with DTAB to be not mandatory but I

am respectfully unable to agree with the said view. I may also notice that the

Single Judge in Macleods Pharmaceuticals Limited though noticed the

earlier judgment of a Single Judge of the same High Court in Cipla Ltd.

supra holding to the contrary but disagreed therewith.

57. Not only so, the petitioners have also placed on record the minutes of

the 68th Meeting of DTAB held on 16th February, 2015 which record that the

issue of rationality of the 294 FDCs was referred to DTAB in its 56 th

Meeting held on 16th January, 2008 and DTAB after consideration of the

matter had constituted a sub-Committee to examine the rationality of these

FDCs. The minutes further record that the said 294 FDCs also were licensed

without approval of the Drugs Controller and though the State Drugs

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 71 of 82
Controllers were asked to withdraw permission for their manufacture but the

manufactures' Association had got stay from the High Court of Madras. The

minutes further record that the sub-Committee so constituted by DTAB had

examined these formulations in consultation with the manufactures'

Association and stakeholders and finalised its Report and which Report was

for review before the DTAB. DTAB, after consideration of the said Report

recommended re-examination of some FDCs and prohibition of certain other

FDCs and further recommended that the High Court of Madras be apprised

thereof for vacation of stay. It thus appears that while in these proceedings it

is contended that the Central Government before issuing the Notification

under Section 26A was not required to consult the DTAB but has itself been

seeking the advice of DTAB and acting thereon in exercise of powers

thereunder. Such inconsistent stand is not understandable.

58. Section 3(h) of the Drugs Act defines patent or proprietary medicine

as a drug which is not included in the edition of Indian Pharmacopoeia or

any other Pharmacopoeia authorised by the Central Government after

consultation with the DTAB. I am of the view that once the Central

Government is not empowered to declare a drug as a patent or proprietary

medicine without consultation with DTAB, so can Central Government be

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 72 of 82
not considered as empowered to declare a drug as risky or not having

therapeutic value or not having therapeutic justification without consultation

with the DTAB.

59. As aforesaid, the Drugs Act does not contain any regulatory

mechanism for manufacture of a drug and the same has been provided under

the Rules only. The Rule making power of the Central Government under

Sections 12, 33 and 33N is also required to be exercised in consultation with

DTAB. The proviso to Section 33 empowers the Central Government to

dispense with such consultation only if the circumstances have arisen which

render it necessary to make rules without such consultation but still provides

for post facto consultation and amendment of the Rules even if framed in

accordance with said consultation. The Legislature thus wherever deemed fit

to empower the Central Government to dispense with such consultation,

provided so.

60. I have already noticed above that under Section 16, the power to

amend the Second Schedule to the Act prescribing standard of quality of

drugs is also to be exercised by the Central Government in consultation with

DTAB.

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 73 of 82
61. Thus, no merit is found in the contention that DTAB is not involved

in the approval of the drugs. Though the Drugs Controller is constituted by

the Rules as the approving authority but the parameters for approval are

prescribed in consultation with the DTAB.

62. Though the respondents in their counter affidavit stated that the matter

was also discussed on 24th July, 2015 at the 48th meeting of the DCC and

which was refuted by the petitioners but a perusal of the minutes of the

subject meeting does not bear out that the decision of the Central

Government impugned in these petitions has the backing of DCC. The

matter before DCC was different.

63. The respondents have also not placed before this Court any

deliberations which may have been held by the Central Government on

receipt of report of Kokate Committee. It is not the case of the respondents

that though a report was obtained from Kokate Committee but was examined

by DTAB, DCC and the Central Drugs Laboratory and they were also

satisfied therewith. What thus emerges is that in the decision making process

leading to the impugned notifications there was a total exclusion of DTAB,

DCC and Central Drugs Laboratory and which in my view cannot be

permitted.
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 74 of 82
64. It was also the contention of the learned ASG that the Federation of

Pharma Entrepreneurs and other Associations of manufacturers of drugs

were fully aware of the constitution of Kokate Committee, the terms of

reference thereof, the scope of enquiry being undertaken by it but did not

object at that time and cannot now impugn the Notifications. It was further

contended that no mala fides have been attributed to Kokate Committee.

65. No merit is found in the aforesaid contention also. There can be no

estopple against the law. Once it is found that the law i.e. the Drugs Act

requires the Central Government to exercise the power under Section 26A

after taking advice from and in consultation with the statutory bodies created

thereunder i.e. the DTAB and DCC, the exercise of power without such

advice and consultation cannot be upheld even if exercised bona fide and in

consultation with and on advice of other experts who may be as competent as

the DTAB and DCC. The maxim, what is prescribed to be done in a

particular way must be done in that way and no other way, would apply.

Reference if any required can be made to Selvi J. Jayalalithaa Vs. State of

Karnataka (2014) 2 SCC 401, Mackinon Mackenzie and Company Ltd. Vs.

Mackinnon Employees Union (2015) 4 SCC 544 and Zuari Cement Ltd.

Vs. Regional Director E.S.I.C. Hyderabad (2015) 7 SCC 690 laying down

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 75 of 82
that if the procedure prescribed is not followed then such act has to be held

to be null and void ab initio in law.

66. Importance and relevance of DTAB can also be gauged from the final

decision in Drugs Action Forum Vs. Union of India supra reported as AIR

SCW (2002) 2644 disposing of the petition by directing DTAB to meet at

least once in six months and the Expert Committee appointed by the DTAB

to look into the question of drug formulations to meet at least once in two

months and to consider the suggestions made by the Drugs Action Forum

from time to time. There would have been no need for such directions to be

issued by the Supreme Court if the Central Government in performance of its

functions under the Drugs Act was to be independent of DTAB and DCC.

67. Thus, the exercise of power by the Central Government in issuing the

impugned Notifications is held to be not in consonance with the provisions

of the Drugs Act. The petitions have to succeed on this ground.

68. The senior counsel for All India Drug Action Network, counsel for

Veteran's Forum for Transparency in Public Life and the counsel for Wing

Commander B.N.P. Singh, General Secretary of Veteran's Forum for

Transparency in Public Life also opposed the petitions inter alia arguing that

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 76 of 82
the Government has acted on the complaints of the patients and concerned

groups and that the health and safety of the patients is paramount and that the

FDCs which have been banned are indeed hazardous to the patient.

69. I have already held above that this Court in exercise of power of

judicial review cannot adjudicate whether these FDCs are risky to the

consumers or lack therapeutic value or therapeutic justification. The statute

requires the said aspects to be considered by DTAB and DCC and to report

thereon. That has admittedly not been done.

70. CM No.1584/2016 in W.P.(C) No.2212/2016 was filed by Indian

Medical Association (IMA) for intervention on the matter. However on

enquiry from the counsel for IMA on 19th May, 2016 as to what is its stand

on the matter, the counsel stated that IMA was supporting the impugned

Notifications and opposing the petitions. However on further enquiry as to

how a decision to oppose the petitions had been taken, whether by holding a

franchise of all members of IMA, the counsel stated that he will have to

obtain instructions and could only state that President of IMA had taken the

decision. However on further enquiry as to the authority of the President of

IMA to take such a decision time was sought to obtain instructions.

Thereafter the counsel for IMA did not appear. The opinion of the members
W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 77 of 82
of IMA being the medical practitioners administering the FDCs subject

matter of these petitions would though have thrown light on the parameters

on which power under Section 26A is to be exercised.

71. Though at one stage of the hearing I had expressed doubts as to the

locus of the Federation of Pharma Entrepreneurs to maintain W.P.(C)

No.2500/2016 impugning all 344 Notifications but the senior counsels for

the petitioners had referred to plethora of case law thereon. Need however to

go into the said aspect is not felt in view of the reasoning hereinabove and

for which alone the petitions are entitled to succeed.

72. Before parting with this subject, for the sake of completeness I may

record that CDSCO is not a Statutory Authority under the Drugs Act. Its

website www.cdsco.nic.in describes it as the Central Drug Authority for

discharging functions assigned to the Central Government under the Drugs

Act, with Drugs Controller at its helm. Interestingly, the Drugs Controller is

not an office established under the Drugs Act; rather Section 5 of the Act

prescribes the DTAB to be having the Drugs Controller as its ex-officio

member. Rule 2(b) defines the Central Licence Approving Authority as the

Drugs Controller appointed by the Central Government.

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 78 of 82
73. In view my findings above, there is no need to go into the other

aspects on which arguments were urged. I may however record my musings

thereon.

74. I had during the hearing enquired as to in exercise of which power the

Central Government had constituted the Kokate Committee to look into the

applications which were received for approval of FDCs from the Central

Government. Under Rule 21(b), the powers of Licensing Authority have

been vested in the Drugs Controller and not the Central Government. I am of

the view that once the Central Government had directed the SLAs to direct

the manufacturers who had obtained licences from them between September,

1988 and October, 2012 for manufacture of FDCs without having the

approval of the Drugs Controller thereof as a new drug, to make applications

therefor, such applications could have been considered by the Drugs

Controller only and none of the provisions of the Act empower the Central

Government to nominate Kokate Committee or any other committee or

person as the Licensing Authority. However need to render any final

decision on the said aspect is not felt as in pursuance to the Report of the

Kokate Committee the applications have not been dealt with. Moreover,

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 79 of 82
there is a provision for appeal against the decision of the Drugs Controller on

an application.

75. There were considerable arguments on the aspect of the need for grant

of a hearing before exercise of powers under Section 26A with respect to a

drug already in use. Though in view of the above there is no need to render

any final decision thereon but I may highlight that Section 16(2) of the Drugs

Act, while empowering the Central Government to amend Schedule -II to

the Act prescribing the standards of quality, requires the same to be done

with a three months notice of intention to do so. It appears that once

amendment of the Schedule prescribing standards of quality (and which may

render a drug already in use as not of standard quality and resultantly require

its manufacture to be stopped) is prescribed to be done after three months

notice, so should ordinarily the power under Section 26A be exercised after

giving notice to the persons who have already been granted permissions to

manufacture the said drug unless there is grave urgency and for which reason

should be recorded. Suffice it is to state that the manner in which the

proceedings till the issuance of the Notification have gone, does not suggest

any such grave urgency.

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 80 of 82
76. To say the least, the Central Government, though acting in public

interest, seems to have gone about it in a haphazard manner. It claims that

the FDCs for manufacture of which licences were issued by SLAs between

September, 1988 and 1st October, 2012 without the same having approval of

the Drugs Controller were wrongly granted such licences. However instead

of taking action for cancellation of said licences, the manufactures were

asked to apply for licences to be Drugs Controller, while continuing to

manufacture the drugs for which according to the Central Government

licence was wrongly given. When such applications were received, instead

of the same being considered by the Drugs Controller, who is vested with the

power of approval, ten committees were constituted for considering the

applications. After the said committees failed to examine all the applications,

the Kokate Committee was constituted. The said Kokate Committee, instead

of considering the applications for approval, went into the aspects of risk to

consumers and therapeutic value and therapeutic justification and on

receiving report whereof impugned Notifications were issued.

77. Though the learned ASG controverted that any opportunity of hearing

is required to be given before exercise of power under Section 26A but as the

aforesaid narrative would show, the Central Government claims to have

W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 81 of 82
issued show cause notices after receipt of report of Kokate Committee and

replies thereto having also been considered by the Kokate Committee.

78. The petitions thus succeed. All 344 Notifications dated 10 th March,

2016 purportedly in exercise of power under section 26A of the Drugs Act

are found to have been issued without following the procedure statutorily

prescribed to be followed prior to issuance thereof and resultantly it is held

that the Notifications are not based on satisfaction of the Central

Government prescribed to be on the advice of an in consultation with the

DTAB and DCC. Resultantly the said Notifications are quashed.

79. The petitions are disposed of.

80. No costs.

RAJIV SAHAI ENDLAW, J.

DECEMBER 1, 2016 ‗bs/gsr/pp' W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 82 of 82 * IN THE HIGH COURT OF DELHI AT NEW DELHI % Date of decision: 1st December, 2016.

+ W.P.(C) No.2212/2016

PFIZER LIMITED & ANR ..... Petitioners Versus UNION OF INDIA & ANR ..... Respondents AND 453 OTHER PETITIONS (SCHEDULE) 1 W.P.(C) 2213/2016 ABBOTT HEALTHCARE PVT LTD & ANR.

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UNION OF INDIA & ANR 2 W.P.(C) 2214/2016 ABBOTT HEALTHCARE PVT LTD & ANR.

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UNION OF INDIA & ANR 5 W.P.(C) 2264/2016 PROCTER & GAMBLE HYGIENE & HEALTHCARE LIMITED VS.

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UNION OF INDIA & ANR 11 W.P.(C) 2272/2016 ALEMBIC PHARMACEUTICALS LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 12 W.P.(C) 2273/2016 ALEMBIC PHARMACEUTICALS LIMITED VS.

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UNION OF INDIA & ANR 14 W.P.(C) 2285/2016 LABORATE PHARMACEUTICALS INDIA LIMITED VS.

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DRUGS CONTROLLER GENERAL OF INDIA & ANR 23 W.P.(C) 2339/2016 AJANTA PHARMA LIMITED & ANR VS.

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DRUGS CONTROLLER GENERAL OF INDIA & ANR 36 W.P.(C) 2352/2016 ALKEM LABORATORIES LTD.

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70 W.P.(C) 2430/2016 LUPIN LIMITED & ANR Vs. UNION OF INDIA & ANR 71 W.P.(C) 2431/2016 M/S GENO PHARMACEUTICALS PVT LIMITED & ANR.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 72 W.P.(C) 2432/2016 M/S GENO PHARMACEUTICALS PVT LIMITED & ANR.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 73 W.P.(C) 2433/2016 M/S GENO PHARMACEUTICALS PVT LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 74 W.P.(C) 2434/2016 LUPIN LIMITED & ANR VS.

UNION OF INDIA & ANR 75 W.P.(C) 2436/2016 M/S GENO PHARMACEUTICALS PVT LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 76 W.P.(C) 2437/2016 M/S GENO PHARMACEUTICALS PVT LIMITED & ANR.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 77 W.P.(C) 2438/2016 GLENMARK PHARMACEUTICALS LIMITED & ANR.

VS.

UNION OF INDIA & ANR 78 W.P.(C) 2453/2016 ALKEM LABORATORIES LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 79 W.P.(C) 2483/2016 SANOFI INDIA LTD. & ANR VS.

UNION OF INDIA & ANR 80 W.P.(C) 2484/2016 INGA LABORATORIES PRIVATE LTD. & ANR.

VS.

UNION OF INDIA & ANR 81 W.P.(C) 2485/2016 LA PRISTINE BIOEUTICALS PVT. LTD.

VS.

UNION OF INDIA & ANR 82 W.P.(C) 2486/2016 LABORATE PHARMACEUTICALS INDIA LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 83 W.P.(C) 2488/2016 KEMWELL BIOPHARMA PVT LTD & ANR.

VS.

UNION OF INDIA & ANR 84 W.P.(C) 2490/2016 LABORATE PHARMACEUTICALS INDIA LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 6 of 31 85 W.P.(C) 2492/2016 OMNI PROTECH DRUGS PVT LTD & ANR VS.

UNION OF INDIA & ANR 86 W.P.(C) 2493/2016 VITAL THERAPEUTICS & FORMULATIONS PVT LTD & ANR VS.

UNION OF INDIA & ANR 87 W.P.(C) 2500/2016 FEDERATION OF PHARMA ENTERPRENEURS & ANR VS.

UNION OF INDIA & ANR 88 W.P.(C) 2511/2016 EMCURE PHARMACEUTICALS LIMITED & ANR.

VS.

UNION OF INDIA & ANR 89 W.P.(C) 2532/2016 M/S ACCENT PHARMA & ORS VS.

UNION OF INDIA & ANR 90 W.P.(C) 2533/2016 IND SWIFT LTD VS.

UNION OF INDIA & ANR 91 W.P.(C) 2534/2016 IND SWIFT LTD VS.

UNION OF INDIA & ANR 92 W.P.(C) 2535/2016 IND SWIFT LTD VS.

UNION OF INDIA & ANR 93 W.P.(C) 2536/2016 TORRENT PHARMACEUTICALS LIMITED VS.

UNION OF INDIA & ANR 94 W.P.(C) 2537/2016 M/S LEEFOLD HEALTHCARE LTD.

VS.

UNION OF INDIA & ANR 95 W.P.(C) 2538/2016 IND SWIFT LTD VS.

UNION OF INDIA & ANR 96 W.P.(C) 2539/2016 STANDARD PHARMACEUTICALS LTD.

VS.

UNION OF INDIA & ANR 97 W.P.(C) 2541/2016 IND SWIFT LTD VS.

UNION OF INDIA & ANR 98 W.P.(C) 2542/2016 IND SWIFT LTD VS.

UNION OF INDIA & ANR 99 W.P.(C) 2543/2016 TABLETS ( INDIA) LIMITED & ANR.

VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 7 of 31 100 W.P.(C) 2544/2016 IND SWIFT LTD VS.

UNION OF INDIA & ANR 101 W.P.(C) 2545/2016 TORRENT PHARMACEUTICALS LTD.

VS.

UNION OF INDIA & ANR 102 W.P.(C) 2546/2016 IND SWIFT LTD VS.

UNION OF INDIA & ANR 103 W.P.(C) 2547/2016 IND SWIFT LTD VS.

UNION OF INDIA & ANR 104 W.P.(C) 2548/2016 M/S SYSTOPIC LABORATORIES PVT LTD. & ANR.

VS.

UNION OF INDIA 105 W.P.(C) 2553/2016 IND SWIFT LTD VS.

UNION OF INDIA & ANR 106 W.P.(C) 2555/2016 IND SWIFT LTD VS.

UNION OF INDIA & ANR 107 W.P.(C) 2556/2016 IND SWIFT LTD VS.

UNION OF INDIA & ANR 108 W.P.(C) 2558/2016 IND SWIFT LTD VS.

UNION OF INDIA & ANR 109 W.P.(C) 2595/2016 M/S LABORATOIRES GRIFFON PVT. LTD. & ANR.

VS.

UNION OF INDIA & ORS 110 W.P.(C) 2599/2016 PHARMED LIMITED & ORS.

VS.

UNION OF INDIA & ANR 111 W.P.(C) 2618/2016 ENTOD PHARMACEUTICALS LTD.

VS.

UNION OF INDIA & ANR 112 W.P.(C) 2621/2016 RUBY ORGANICS PRIVATE LIMITED & ORS VS.

UNION OF INDIA & ANR 113 W.P.(C) 2622/2016 AKUMS DRUGS & PHARMACEUTICALS LTD.

VS.

UNION OF INDIA & ANR 114 W.P.(C) 2623/2016 USV PRIVATE LIMITED & ANR VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 8 of 31 115 W.P.(C) 2625/2016 M/S. NEM LABORATORIES PVT. LTD.

VS.

UNION OF INDIA & ORS 116 W.P.(C) 2626/2016 M/S MICRO LABS LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 117 W.P.(C) 2627/2016 ARISTO PHARMACEUTICALS LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 118 W.P.(C) 2630/2016 USV PRIVATE LIMITED & ANR VS.

UNION OF INDIA & ANR 119 W.P.(C) 2631/2016 M/S. INDOCO REMEDIES LTD. & ANR.

VS.

UNION OF INDIA & ANR 120 W.P.(C) 2632/2016 M/S ARISTO PHARMACEUTICALS PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 121 W.P.(C) 2633/2016 M/S ARISTO PHARMACEUTICALS PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 122 W.P.(C) 2634/2016 M/S. INDOCO REMEDIES LTD. & ANR.

VS.

UNION OF INDIA & ANR 123 W.P.(C) 2636/2016 USV PRIVATE LIMITED & ANR VS.

UNION OF INDIA & ANR 124 W.P.(C) 2637/2016 ERIS LIFESCIENCES PRIVATE LIMITED VS.

UNION OF INDIA & ANR 125 W.P.(C) 2638/2016 FDC LIMITED & ANR VS.

UNION OF INDIA & ANR 126 W.P.(C) 2639/2016 M/S MICRO LABS LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 127 W.P.(C) 2643/2016 M/S. INDOCO REMEDIES LTD. & ANR.

VS.

UNION OF INDIA & ANR 128 W.P.(C) 2644/2016 M/S. INDOCO REMEDIES LTD. & ANR.

VS.

UNION OF INDIA & ANR 129 W.P.(C) 2666/2016 ALKEM LABORATORIES LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 9 of 31 130 W.P.(C) 2667/2016 ALKEM LABORATORIES LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 131 W.P.(C) 2676/2016 COMED CHEMICALS LTD & ANR VS.

UNION OF INDIA & ANR 132 W.P.(C) 2677/2016 MANKIND PHARMA LTD & ORS VS.

UNION OF INDIA & ANR 133 W.P.(C) 2678/2016 ALKEM LABORATORIES LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 134 W.P.(C) 2679/2016 ALKEM LABORATORIES LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 135 W.P.(C) 2680/2016 ALKEM LABORATORIES LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 136 W.P.(C) 2682/2016 VIVIMED LABS LIMITED & ANR VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 137 W.P.(C) 2683/2016 MERCK LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 138 W.P.(C) 2689/2016 M/S BIOLOGICAL E LTD. & ANR VS.

UNION OF INDIA & ANR 139 W.P.(C) 2697/2016 ZEE LABORATORIES LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 140 W.P.(C) 2698/2016 COPPER PHARMA LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 141 W.P.(C) 2703/2016 M/S. INDOCO REMEDIES LTD. & ANR.

VS.

UNION OF INDIA & ANR 142 W.P.(C) 2709/2016 M/S. INDOCO REMEDIES LTD. & ANR.

VS.

UNION OF INDIA & ANR 143 W.P.(C) 2713/2016 VARAV BIOGENESIS PVT LTD & ANR.

VS.

UNION OF INDIA & ANR 144 W.P.(C) 2714/2016 M/S. INDOCO REMEDIES LTD. & ANR.

VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 10 of 31 145 W.P.(C) 2715/2016 VARAV BIOGENESIS PVT LTD & LTD.

VS.

UNION OF INDIA & ANR 146 W.P.(C) 2716/2016 HORIZON BIOCEUTICALS PVT LTD & ANR VS.

UNION OF INDIA & ANR 147 W.P.(C) 2717/2016 VARAV BIOGENESIS PVT LTD & LTD.

VS.

UNION OF INDIA & ANR 148 W.P.(C) 2718/2016 VARAV BIOGENESIS PVT LTD & LTD.

VS.

UNION OF INDIA & ANR 149 W.P.(C) 2719/2016 VARAV BIOGENESIS PVT LTD & LTD.

VS.

UNION OF INDIA & ANR 150 W.P.(C) 2720/2016 VARAV BIOGENESIS PVT LTD & LTD.

VS.

UNION OF INDIA & ANR 151 W.P.(C) 2721/2016 VARAV BIOGENESIS PVT LTD & LTD.

VS.

UNION OF INDIA & ANR 152 W.P.(C) 2722/2016 HORIZON BIOCEUTICALS PVT LTD & ANR VS.

UNION OF INDIA & ANR 153 W.P.(C) 2727/2016 ZEN LABS INDIA & ORS VS.

UNION OF INDIA & ANR 154 W.P.(C) 2733/2016 ZOTA HEALTHCARE LIMITED VS.

UNION OF INDIA & ANR 155 W.P.(C)2762/2016 LINCOLN PHARMACEUTICALS LIMITED & ANR VS.

UNION OF INDIA & ANR 156 W.P.(C) 2763/2016 PSYCHOTROPICS INDIA LIMITED VS.

UNION OF INDIA & ANR 157 W.P.(C) 2764/2016 LINCOLN PHARMACEUTICALS LIMITED & ORS VS.

UNION OF INDIA & ANR 158 W.P.(C) 2765/2016 CORONA REMEDIES PRIVATE LIMITED & ORS VS.

UNION OF INDIA & ANR 159 W.P.(C) 2777/2016 HORIZON BIOCEUTICALS PVT LTD & ANR VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 11 of 31 160 W.P.(C) 2778/2016 HORIZON BIOCEUTICALS PVT LTD & ANR VS.

UNION OF INDIA & ANR 161 W.P.(C) 2779/2016 HORIZON BIOCEUTICALS PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 162 W.P.(C) 2780/2016 HORIZON BIOCEUTICALS PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 163 W.P.(C) 2781/2016 HORIZON BIOCEUTICALS PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 164 W.P.(C) 2782/2016 HORIZON BIOCEUTICALS PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 165 W.P.(C) 2783/2016 HORIZON BIOCEUTICALS PVT. LTD. & ANR VS.

UNION OF INDIA & ORS 166 W.P.(C) 2784/2016 HORIZON BIOCEUTICALS PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 167 W.P.(C) 2785/2016 HORIZON BIOCEUTICALS PVT LTD & ANR VS.

UNION OF INDIA & ANR 168 W.P.(C) 2786/2016 VARAV BIOGENESIS PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 169 W.P.(C) 2787/2016 HORIZON BIOCEUTICALS PVT LTD & ANR VS.

UNION OF INDIA & ANR 170 W.P.(C) 2788/2016 HORIZON BIOCEUTICALS PVT LTD. & ANR VS.

UNION OF INDIA & ANR 171 W.P.(C) 2789/2016 HORIZON BIOCEUTICALS PVT LTD & ANR VS.

UNION OF INDIA & ANR 172 W.P.(C) 2834/2016 M/S WINGS PHARMACEUTICALS PVT. LTD. & ANR VS.

UNION OF INDIA 173 W.P.(C) 2843/2016 M/S WINGS PHARMACEUTICALS PVT. LTD. & ANR VS.

UNION OF INDIA 174 W.P.(C) 2863/2016 J.B. CHEMICALS & PHARMACEUTICALS LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 12 of 31 175 W.P.(C) 2864/2016 J.B. CHEMICALS & PHARMACEUTICALS LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 176 W.P.(C) 2865/2016 J.B. CHEMICALS & PHARMACEUTICALS LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 177 W.P.(C) 2867/2016 J.B. CHEMICALS & PHARMACEUTICALS LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 178 W.P.(C) 2884/2016 M/S WINGS PHARMACEUTICALS PVT. LTD. & ANR VS.

UNION OF INDIA 179 W.P.(C) 2915/2016 MACLEODS PHARMACEUTICALS LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 180 W.P.(C) 2942/2016 M/S TRIKO PHARMACEUTICALS VS.

UNION OF INDIA 181 W.P.(C) 2968/2016 AMTEX PHARMA PVT LTD & ANR VS.

UNION OF INDIA & ANR 182 W.P.(C) 2971/2016 ANTEX PHARMA PVT LTD & ANR VS.

UNION OF INDIA & ANR 183 W.P.(C) 2984/2016 M/S TRIKO PHARMACEUTICALS VS.

UNION OF INDIA 184 W.P.(C) 3009/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR 185 W.P.(C) 3046/2016 ANTEX PHARMA PRIVATE LIMITED VS.

UNION OF INDIA & ANR 186 W.P.(C) 3053/2016 USV PRIVATE LIMITED & ANR VS.

UNION OF INDIA & ANR 187 W.P.(C) 3056/2016 USV PRIVATE LIMITED & ANR VS.

UNION OF INDIA & ANR 188 W.P.(C) 3057/2016 USV PRIVATE LIMITED & ANR VS.

UNION OF INDIA & ANR 189 W.P.(C) 3058/2016 USV PRIVATE LIMITED & ANR VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 13 of 31 190 W.P.(C) 3063/2016 USV PRIVATE LIMITED & ANR VS.

UNION OF INDIA & ANR 191 W.P.(C) 3095/2016 RUSSIAN REMEDIES (DIVISION OFANTEX PHARMA PVT LTD) VS.

UNION OF INDIA & ANR 192 W.P.(C) 3096/2016 RUSSIAN REMEDIES (DIVISION OFANTEX PHARMA PVT LTD) VS.

UNION OF INDIA & ANR 193 W.P.(C) 3098/2016 RUSSIAN REMEDIES (DIVISION OFANTEX PHARMA PVT LTD) VS.

UNION OF INDIA & ANR 194 W.P.(C) 3100/2016 RUSSIAN REMEDIES (DIVISION OFANTEX PHARMA PVT LTD) VS.

UNION OF INDIA & ANR 195 W.P.(C) 3102/2016 RUSSIAN REMEDIES (DIVISION OFANTEX PHARMA PVT LTD) VS.

UNION OF INDIA & ANR 196 W.P.(C) 3120/2016 HETERO HEALTHCARE LTD & ANR VS.

UNION OF INDIA & ANR 197 W.P.(C) 3160/2016 WOCKHARDT LIMITED VS.

UNION OF INDIA & ANR 198 W.P.(C) 3171/2016 AEON FORMULATIONS PVT. LTD VS.

UNION OF INDIA & ANR 199 W.P.(C) 3172/2016 M/S SUNGLOW PHARMACEUTICALS PVT. LTD.

VS.

UNION OF INDIA & ANR 200 W.P.(C) 3173/2016 FOURRTS (INDIA) LABORATORIS PVT. LTD.

VS.

UNION OF INDIA & ANR 201 W.P.(C) 3175/2016 INDCHEMIE HEALTH SPECIALITIES PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 202 W.P.(C) 3176/2016 INDCHEMIE HEALTH SPECIALITIES PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 203 W.P.(C) 3177/2016 AKUMS DRUGS & PHARMACEUTICALS LIMITED VS.

UNION OF INDIA & ANR 204 W.P.(C) 3178/2016 INDCHEMIE HEALTH SPECIALITIES PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 14 of 31 205 W.P.(C) 3179/2016 BLUE CROSS LABORATORIES PRIVATE LTD & ANR VS.

UNION OF INDIA & ANR 206 W.P.(C) 3180/2016 INDCHEMIE HEALTH SPECIALITIES PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 207 W.P.(C) 3189/2016 BLUE CROSS LABORATORIES PRIVATE LTD & ANR VS.

UNION OF INDIA & ANR 208 W.P.(C) 3227/2016 M/S SRISHTI BIOTEC VS.

UNION OF INDIA & ANR 209 W.P.(C) 3228/2016 M/S SKAN RESEARCH LAB (P) LTD.

VS.

UNION OF INDIA & ANR 210 W.P.(C) 3229/2016 MACLEODS PHARMACEUTICALS LIMITED VS.

DRUG CONTROLLER GENERAL OF INDIA & ANR 211 W.P.(C) 3232/2016 M/S SRISHTI BIOTEC VS.

UNION OF INDIA & ANR 212 W.P.(C) 3233/2016 M/S SKAN RESEARCH LAB (P) LTD.

VS.

UNION OF INDIA & ANR 213 W.P.(C) 3234/2016 M/S SKAN RESEARCH LAB (P) LTD.

VS.

UNION OF INDIA & ANR 214 W.P.(C) 3238/2016 M/S SKN ORGANICS (P) LTD.

VS.

UNION OF INDIA & ANR 215 W.P.(C) 3239/2016 M/S SKAN RESEARCH LAB PVT. LTD.

VS.

UNION OF INDIA & ANR 216 W.P.(C) 3240/2016 M/S SKAN RESEARCH LAB (P) LTD.

VS.

UNION OF INDIA & ANR 217 W.P.(C) 3243/2016 M/S SKN ORGANICS PVT. LTD.

VS.

UNION OF INDIA & ANR 218 W.P.(C) 3247/2016 CACHET PHARMACEUTICALS PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 219 W.P.(C) 3250/2016 CACHET PHARMACEUTICALS PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 15 of 31 220 W.P.(C) 3251/2016 CACHET PHARMACEUTICALS PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 221 W.P.(C) 3252/2016 M/S MEDICHEM ENTERPRISES & ANR VS.

UNION OF INDIA & ANR 222 W.P.(C) 3253/2016 MEPROHAX LIFESCIENCES PRIVATE LIMITED VS.

UNION OF INDIA & ANR 223 W.P.(C) 3254/2016 MACLEODS PHARMACEUTICALS LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 224 W.P.(C) 3255/2016 MACMILLON PHARMACEUTICALS LTD.

VS.

UNION OF INDIA & ANR 225 W.P.(C) 3257/2016 BIOCON LTD. & ANR VS.

UNION OF INDIA & ANR 226 W.P.(C) 3259/2016 HEMA LABORATORIES PRIVATE LIMITED VS.

UNION OF INDIA & ANR 227 W.P.(C) 3261/2016 SAHIL MAHAJAN VS.

UNION OF INDIA & ANR 228 W.P.(C) 3262/2016 KOYE PHARMACEUTICALS PRIVATE LIMITED & ANR VS.

UNION OF INDIA & ANR 229 W.P.(C) 3263/2016 VIVIMED LABS LIMITED & ANR VS.

UNION OF INDIA & ANR 230 W.P.(C) 3264/2016 CACHET PHARMACEUTICALS PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 231 W.P.(C) 3266/2016 CACHET PHARMACEUTICALS PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 232 W.P.(C) 3268/2016 CONFEDERATION OF INDIAN INDIA PHARMACEUTICAL INDUSTRY (SSI) VS.

UNION OF INDIA & ANR 233 W.P.(C) 3335/2016 WANBURY LIMITED & ANR VS.

UNION OF INDIA 234 W.P.(C) 3341/2016 WANBURY LIMITED & ANR VS.

UNION OF INDIA W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 16 of 31 235 W.P.(C) 3642/2016 BIOSEARCH ORGANICS VS.

UNION OF INDIA & ANR 236 W.P.(C) 3770/2016 GENX PHARMA LIMITED & ORS VS.

UNION OF INDIA & ANR 237 W.P.(C) 3781/2016 HETERO HEALTHCARE LTD. & ORS VS.

UNION OF INDIA & ANR 238 W.P.(C) 3814/2016 MEDSOL INDIA OVERSEAS PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 239 W.P.(C) 3851/2016 M/S LARK LABORATORIES INDIA LTD. & ANR VS.

UNION OF INDIA & ANR 240 W.P.(C) 3856/2016 ACRON PHARMACEUTICALS VS.

UNION OF INDIA & ANR 241 W.P.(C) 3862/2016 CENTAUR PHARMACEUTICALS PVT. LTD. & ANR.

VS.

UNION OF INDIA & ANR 242 W.P.(C) 3863/2016 M/S UNICURE INDIA LTD.

VS.

UNION OF INDIA & ANR 243 W.P.(C) 3864/2016 CENTAUR PHARMACEUTICALS PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 244 W.P.(C) 3865/2016 CENTAUR PHARMACEUTICALS PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 245 W.P.(C) 3869/2016 SOMATICO PHARMACAL PVT. LTD.

VS.

UNION OF INDIA & ANR 246 W.P.(C) 3870/2016 M/S OBSURGE BIOTECH LTD.

VS.

UNION OF INDIA & ANR 247 W.P.(C) 3871/2016 CENTAUR PHARMACEUTICALS PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 248 W.P.(C) 3901/2016 PHARMA SYNTH FORMULATIONS LTD.

VS.

UNION OF INDIA & ANR 249 W.P.(C) 3902/2016 OZONE PHARMACEUTICALS LTD.

VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 17 of 31 250 W.P.(C) 3903/2016 SEAGULL LABORATORIES (I) P. LTD.

VS.

UNION OF INDIA & ANR 251 W.P.(C) 3904/2016 SEAGULL LABORATORIES (I) P. LTD.

VS.

UNION OF INDIA & ANR 252 W.P.(C) 3905/2016 OZONE PHARMACEUTICALS LTD.

VS.

UNION OF INDIA & ANR 253 W.P.(C) 3907/2016 SUN PHARMACEUTICALS INDUSTRIES LTD. & ANR VS.

UNION OF INDIA & ANR 254 W.P.(C) 3917/2016 APEX LABORATORIES PRIVATE LIMITED VS.

UNION OF INDIA & ANR 255 W.P.(C) 3920/2016 CENTAUR PHARMACEUTICALS PVT. LTD. & ORS VS.

UNION OF INDIA & ANR 256 W.P.(C) 3923/2016 RIVPRA FORMULATION PRIVATE LIMITED & ANR VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 257 W.P.(C) 3928/2016 DAKSH PHARMACEUTICALS PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 258 W.P.(C) 3930/2016 ORDAIN HEALTHCARE GLOBAL PRIVATE LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 259 W.P.(C) 3936/2016 REGENT AJANTA BIOTECH VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 260 W.P.(C) 3937/2016 CENTAUR PHARMACEUTICALS PVT. LTD. & ORS VS.

UNION OF INDIA & ANR 261 W.P.(C) 3938/2016 M/S SEAGULL PHARMACEUTICAL PVT. LTD.

VS.

UNION OF INDIA & ANR 262 W.P.(C) 3939/2016 CENTAUR PHARMACEUTICALS PVT. LTD. & ORS VS.

UNION OF INDIA & ANR 263 W.P.(C) 3940/2016 CENTAUR PHARMACEUTICALS PVT. LTD. & ORS VS.

UNION OF INDIA & ANR 264 W.P.(C) 3942/2016 AKMUS DRUGS & PHARMACEUTICALS LIMITED VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 18 of 31 265 W.P.(C) 3957/2016 CENTAUR PHARMACEUTICALS PVT. LTD. & ORS VS.

UNION OF INDIA & ANR 266 W.P.(C) 3963/2016 M/S MICRO LABS LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 267 W.P.(C) 3964/2016 SAMSON LABORATORIES PVT. LTD.

VS.

UNION OF INDIA & ANR 268 W.P.(C) 3965/2016 MED MANOR ORGANICS PVT. LTD.

VS.

UNION OF INDIA & ANR 269 W.P.(C) 3979/2016 SUN PHARMACEUTICALS INDUSTRIES LTD. & ANR VS.

UNION OF INDIA & ANR 270 W.P.(C) 3980/2016 MERIDIAN MEDICARE LIMITED VS.

UNION OF INDIA & ANR 271 W.P.(C) 3981/2016 JENBURKT PHARMACEUTICALS LTD. & ANR VS.

UNION OF INDIA & ANR 272 W.P.(C) 3982/2016 ELAN PHARMA (INDIA) PVT. LTD.

VS.

UNION OF INDIA & ANR 273 W.P.(C) 3990/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR 274 W.P.(C) 3991/2016 INTAS PHARMACEUTICALS LIMITED & ANR VS.

UNION OF INDIA & ANR 275 W.P.(C) 3993/2016 JENBURKT PHARMACEUTICALS LTD. & ANR VS.

UNION OF INDIA & ANR 276 W.P.(C) 3994/2016 JENBURKT PHARMACEUTICALS LTD. & ANR VS.

UNION OF INDIA & ANR 277 W.P.(C) 3996/2016 INTAS PHARMACEUTICALS LIMITED & ANR VS.

UNION OF INDIA & ANR 278 W.P.(C) 3997/2016 INTAS PHARMACEUTICALS LIMITED & ANR VS.

UNION OF INDIA & ANR 279 W.P.(C) 3999/2016 M/S MEDOPHARM VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 19 of 31 280 W.P.(C) 4000/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR 281 W.P.(C) 4001/2016 JENBURKT PHARMACEUTICALS LTD. & ANR VS.

UNION OF INDIA & ANR 282 W.P.(C) 4006/2016 INTAS PHARMACEUTICALS LIMITED & ANR VS.

UNION OF INDIA & ANR 283 W.P.(C) 4007/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR 284 W.P.(C) 4041/2016 REXCIN PHARMACEUTICAL PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 285 W.P.(C) 4046/2016 M/S SALUTE BESTOCHEM & ANR VS.

UNION OF INDIA 286 W.P.(C) 4051/2016 M/S SALUTE BESTOCHEM & ANR VS.

UNION OF INDIA 287 W.P.(C) 4052/2016 M/S SALUTE BESTOCHEM & ANR VS.

UNION OF INDIA 288 W.P.(C) 4063/2016 M/S UNIVERSAL TWIN LABS VS.

UNION OF INDIA 289 W.P.(C) 4064/2016 M/S UNIVERSAL TWIN LABS VS.

UNION OF INDIA 290 W.P.(C) 4073/2016 M/S SALUTE BESTOCHEM & ANR VS.

UNION OF INDIA 291 W.P.(C) 4074/2016 M/S SALUTE BESTOCHEM & ANR VS.

UNION OF INDIA 292 W.P.(C) 4105/2016 PURO PHARMA LABORATORIES VS.

UNION OF INDIA & ANR 293 W.P.(C) 4107/2016 NAVIL LABORATORIES VS.

UNION OF INDIA & ANR 294 W.P.(C) 4108/2016 CHINUBHAI PHARMA PVT. LTD. & ANR VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 20 of 31 295 W.P.(C) 4115/2016 LINCOLN PARENTERAL LIMITED VS.

UNION OF INDIA & ANR 296 W.P.(C) 4139/2016 GUJARAT TERCE LABORATORIES LIMITED & ANR VS.

UNION OF INDIA & ANR 297 W.P.(C) 4148/2016 TIDAL LABORATORIES PVT. LTD.

VS.

UNION OF INDIA & ANR 298 W.P.(C) 4188/2016 DALLAS FORMILATIONS PVT. LTD.

VS.

UNION OF INDIA & ANR 299 W.P.(C) 4205/2016 OZONE PHARMACEUTICALS LTD.

VS.

UNION OF INDIA & ANR 300 W.P.(C) 4207/2016 M/S CREATIVE HEALTHCARE PVT. LTD.

VS.

UNION OF INDIA & ANR 301 W.P.(C) 4216/2016 OZONE PHARMACEUTICALS LTD.

VS.

UNION OF INDIA & ANR 302 W.P.(C) 4236/2016 TORQUE PHARMACEUTICALS PRIVATE LIMITED VS.

UNION OF INDIA & ANR 303 W.P.(C) 4239/2016 M/S CHIMAK HEALTH CARE VS.

UNION OF INDIA & ANR 304 W.P.(C) 4240/2016 M/S INNOVA CAPTAB VS.

UNION OF INDIA & ANR 305 W.P.(C) 4245/2016 M/S D M PHARMA VS.

UNION OF INDIA & ANR 306 W.P.(C) 4247/2016 KUSUM HEALTHCARE P. LTD VS.

UNION OF INDIA & ANR 307 W.P.(C) 4248/2016 M/S. AUSTRO LABS LTD.

VS.

UNION OF INDIA & ANR 308 W.P.(C) 4257/2016 CURETECH SKINCARE VS.

UNION OF INDIA & ANR 309 W.P.(C) 4262/2016 INNOVA CAPTAB PRIVATE LIMITED VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 21 of 31 310 W.P.(C) 4263/2016 M/S CHIROS PHARMA VS.

UNION OF INDIA & ANR 311 W.P.(C) 4264/2016 BIOCHEMIX HEALTHCARE PVT LTD VS.

UNION OF INDIA & ANR 312 W.P.(C) 4265/2016 M/S SUNDYOTA NUMANDIS PHARMACEUTICALS P LTD & ANR VS.

UNION OF INDIA & ANR 313 W.P.(C) 4266/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR 314 W.P.(C) 4267/2016 YASH PHARMA LABORATORIES PRIVATE LIMITED & ANR VS.

UNION OF INDIA & ANR 315 W.P.(C) 4270/2016 SKYMAP PHARMACEUTICALS PRIVATE LIMITED VS. UOI & ANR 316 W.P.(C) 4272/2016 UNIBIOTECH FORMULATION VS. DRUGS CONTROLLER GENERAL OF INDIA & ANR 317 W.P.(C) 4273/2016 KASH MEDICARE PVT LTD VS. DRUGS CONTROLLER GENERAL OF INDIA & ANR 318 W.P.(C) 4274/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS. UNION OF INDIA & ANR 319 W.P.(C) 4282/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS. UNION OF INDIA & ANR 320 W.P.(C) 4288/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS. UNION OF INDIA & ANR 321 W.P.(C) 4289/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS. UNION OF INDIA & ANR 322 W.P.(C) 4290/2016 RPG LIFE SCIENCES LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 323 W.P.(C) 4291/2016 M/S HAB PHARMACEUTICALS & RESEARCH LIMITED VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 324 W.P.(C) 4295/2016 SURAKSHA PHARMA PVT LTD VS.

UOI & ANR 325 W.P.(C) 4297/2016 YASH PHARMA LABORATORIES PRIVATE LIMITED & ANR VS.

UNION OF INDIA & ANR 326 W.P.(C) 4298/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR 327 W.P.(C) 4299/2016 M/S RAPROSS PHARMACEUTICALS (P) LTD.

VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 22 of 31 328 W.P.(C) 4300/2016 UNIMARCK PHARMA (INDIA) LTD VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 329 W.P.(C) 4304/2016 WINGS PHARMACEUTICALS PVT LTD & ANR VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 330 W.P.(C) 4305/2016 M/S EAST AFRICAN INDIA OVERSEAS VS.

UNION OF INDIA & ANR 331 W.P.(C) 4306/2016 M/S SALUD CARE (I) PVT. LTD VS.

UNION OF INDIA & ANR 332 W.P.(C) 4307/2016 MANCARE HEALTH PVT LTD VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 333 W.P.(C) 4348/2016 LIFE CARE FORMULATIONS PVT LTD.

VS.

UNION OF INDIA & ANR 334 W.P.(C) 4349/2016 UNISON PHARAMACEUTICALS PVT. LTD VS.

UNION OF INDIA & ANR 335 W.P.(C) 4350/2016 JENBURKT PHARMACEUTICALS LTD & ANR VS.

UNION OF INDIA & ANR 336 W.P.(C) 4351/2016 M/S JUPITER PHARMACEUTICALS LTD VS.

UNION OF INDIA & ANR 337 W.P.(C) 4352/2016 MACSUR PHARMAA INDIA PVT LTD VS.

UNION OF INDIA & ANR 338 W.P.(C) 4353/2016 M/S NULIFE PHARMACEUTICALS VS.

UNION OF INDIA 339 W.P.(C) 4354/2016 UNISON PHARAMACEUTICALS PVT LTD VS.

UNION OF INDIA & ANR 340 W.P.(C) 4355/2016 UNISON PHARMACEUTICAL PVT LTD & ANR VS.

UNION OF INDIA & ANR 341 W.P.(C) 4356/2016 CHETANBHAI S. SHAH & ORS VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 342 W.P.(C) 4359/2016 STRASSENBURG PHARMACEUTICALS LIMITED VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 23 of 31 343 W.P.(C) 4360/2016 TTK HEALTH CARE & ORS VS.

UNION OF INDIA & ANR 344 W.P.(C) 4361/2016 M/S SYMBIOTIC DRUGS & DIABETIC CARE PVT. LTD.

VS.

UNION OF INDIA & ANR 345 W.P.(C) 4362/2016 FOURRTS (INDIA) LABORATORIES PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 346 W.P.(C) 4363/2016 MED MANOR ORGANICS PVT. LTD.

VS.

UNION OF INDIA & ANR 347 W.P.(C) 4478/2016 KUEMEN LABORATORIES PVT. LTD VS.

UNION OF INDIA & ANR 348 W.P.(C) 4512/2016 GALPHA LABORATORIES LTD.

VS.

UNION OF INDIA & ANR 349 W.P.(C) 4526/2016 M/S SALUTE BESTOCHEM & ANR VS.

UNION OF INDIA 350 W.P.(C) 4595/2016 SEAGULL LABORATORIES (I) P LTD Vs. UNION OF INDIA & ANR 351 W.P.(C) 4597/2016 CENTAUR PHARMACEUTICALS PVT LIMITED & ORS Vs. UNION OF INDIA & ANR 352 W.P.(C) 4598/2016 SEAGULL LABORATOIRES (I) P LTD.

VS.

UNION OF INDIA & ANR 353 W.P.(C) 4612/2016 AKUMS DRUGS & PHARMACEUTICALS LIMITED VS.

UNION OF INDIA & ANR 354 W.P.(C) 4613/2016 M/S SYSTOPIC LABORATORIES PVT. LTD. & ANR VS.

UNION OF INDIA 355 W.P.(C) 4614/2016 SAYORA PHARMA PVT. LTD.

VS.

UNION OF INDIA & ORS 356 W.P.(C) 4615/2016 M/S SYSTOPIC LABORATORIES PVT. LTD. & ANR VS.

UNION OF INDIA 357 W.P.(C) 4617/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR 358 W.P.(C) 4618/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 24 of 31 359 W.P.(C) 4619/2016 M/S FRANKLIN LABORATORIES (I) PVT. LTD.

VS.

UNION OF INDIA & ANR 360 W.P.(C) 4620/2016 M/S BEEKAY PHARMACEUTICALS VS.

UNION OF INDIA & ANR 361 W.P.(C) 4621/2016 M/S PSYCO REMEDIES LTD VS.

UNION OF INDIA & ANR 362 W.P.(C) 4622/2016 MASCOT HEALTH SERIES PVT LTD VS.

UNION OF INDIA & ANR 363 W.P.(C) 4623/2016 M/S CONSERN PHARMA PVT LTD VS.

UNION OF INDIA & ANR 364 W.P.(C) 4624/2016 BIOGENETIC DRUGS PVT LTD VS.

UNION OF INDIA & ANR 365 W.P.(C) 4625/2016 MEDIMARK DRUGS & PHARMACEUTICALS VS.

UNION OF INDIA & ANR 366 W.P.(C) 4626/2016 SMILAX HEALTHCARE PVT LTD VS.

UNION OF INDIA & ANR 367 W.P.(C) 4627/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR 368 W.P.(C) 4628/2016 NECTAR BIOPHARMA PRIVATE LIMITED VS.

UNION OF INDIA & ANR 369 W.P.(C) 4629/2016 AMWIN PHARMACEUTICALS VS.

UNION OF INDIA & ANR 370 W.P.(C) 4642/2016 M/S EDIFICE LABORATORIES VS.

UNION OF INDIA & ANR 371 W.P.(C) 4643/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR 372 W.P.(C) 4644/2016 M/S MICRO LABS LIMITED VS.

UNION OF INDIA & ANR 373 W.P.(C) 4645/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 25 of 31 374 W.P.(C) 4646/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR 375 W.P.(C) 4647/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR 376 W.P.(C) 4648/2016 INTAS PHARMACEUTICAL LIMITED & ANR VS.

UNION OF INDIA & ANR 377 W.P.(C) 4654/2016 CARE FORMULATION LABS PVT. LTD.

VS.

UNION OF INDIA & ANR 378 W.P.(C) 4655/2016 M/S FRANCO INDIAN PHARMACEUTICALS PVT.LTD. & ANR VS.

UNION OF INDIA & ORS 379 W.P.(C) 4656/2016 M/S MAXTAR BIOGENICS VS.

UNION OF INDIA & ANR 380 W.P.(C) 4657/2016 M/S FRANCO INDIAN PHARMACEUTICALS PVT.LTD. & ANR VS.

UNION OF INDIA & ORS 381 W.P.(C) 4658/2016 M/S FRANCO INDIAN PHARMACEUTICALS PVT.LTD. & ANR VS.

UNION OF INDIA & ORS 382 W.P.(C) 4659/2016 M/S FRANCO INDIAN PHARMACEUTICALS PVT.LTD.

VS.

UNION OF INDIA & ORS 383 W.P.(C) 4674/2016 M/S FRANCO INDIAN PHARMACEUTICALS PVT.LTD. & ANR VS.

UNION OF INDIA & ORS 384 W.P.(C) 4675/2016 M/S FRANCO INDIAN PHARMACEUTICALS PVT.LTD. & ANR VS.

UNION OF INDIA & ORS 385 W.P.(C) 4764/2016 TIMON PHARMACEUTICALS PVT LTD VS.

UOI & ANR 386 W.P.(C) 4918/2016 M/S ALIVE HEALTHCARE VS.

UNION OF INDIA & ANR 387 W.P.(C) 4919/2016 M/S MALIK LIFE SCIENCES PVT. LTD.

VS.

UNION OF INDIA & ANR 388 W.P.(C) 4920/2016 M/S COMBITIC GLOBAL CAPLET PVT. LTD.

VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 26 of 31 389 W.P.(C) 4921/2016 ORGANIC LABS PVT LTD VS.

UNION OF INDIA & ANR 390 W.P.(C) 4922/2016 MDC PHARMACEUTICALS (P) LTD VS.

UNION OF INDIA & ANR 391 W.P.(C) 4923/2016 SINSAN PHARMACEUTICAL PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 392 W.P.(C) 4924/2016 M/S ANPHAR ORGANICS PVT LTD VS.

UNION OF INDIA 393 W.P.(C) 4926/2016 SINSAN PHARMACEUTICAL PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 394 W.P.(C) 4927/2016 M/S PURE & CURE HEALTHCARE PVT. LTD.

VS.

UNION OF INDIA & ANR 395 W.P.(C) 4963/2016 VARAV BIOGENSIS PVT LTD VS.

UNION OF INDIA & ANR 396 W.P.(C) 4964/2016 M/S IOSIS REMEDIES VS.

UNION OF INDIA & ANR 397 W.P.(C) 4965/2016 THREE B HEALTHCARE LIMITED VS.

UNION OF INDIA & ANR 398 W.P.(C) 4966/2016 GLACIER PHARMACEUTICAL PVT. LTD. & ANR VS.

UNION OF INDIA & ANR 399 W.P.(C) 4967/2016 M/S SCOTT-EDIL PHARMACIA LIMITED VS.

UNION OF INDIA & ANR 400 W.P.(C) 4968/2016 HORIZONE BIOCEUTICALS PVT LTD VS.

UNION OF INDIA & ANR 401 W.P.(C) 4969/2016 ARION HEALTHCARE VS.

UNION OF INDIA & ANR 402 W.P.(C) 4971/2016 APPLE FORMULATIONS PVT. LTD.

VS.

UNION OF INDIA & ANR 403 W.P.(C) 4975/2016 TIMON PHARMACEUTICALS PVT LTD VS.

UOI & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 27 of 31 404 W.P.(C) 4982/2016 TOSC INTERNATIONAL PVT. LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 405 W.P.(C) 4985/2016 INTAS PHARMACEUTICALS LIMITED & ANR VS.

UNION OF INDIA & ANR 406 W.P.(C) 5002/2016 GALPHA LABORATORIES LTD.

VS.

UNION OF INDIA & ORS.

407 W.P.(C) 5258/2016 SMART LABORATORIES PVT. LTD.

VS.

UNION OF INDIA & ANR 408 W.P.(C) 5260/2016 M/S APTUS PHARMA PVT. LTD.

VS.

UNION OF INDIA & ANR 409 W.P.(C) 5264/2016 COOPER PHARMA LTD VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 410 W.P.(C) 5265/2016 M/S SYNCHEM LABORATORIES PVT. LTD.

VS.

UNION OF INDIA & ANR 411 W.P.(C) 5266/2016 M/S. GS PHARMACEUTICALS PVT LTD.

VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 412 W.P.(C) 5267/2016 M/S. GS PHARMACEUTICALS PVT LTD VS.

DRUGS CONTROLLER GENERAL OF INDIA & ANR 413 W.P.(C) 5303/2016 M/S KEE PHARMA LIMITED VS.

UNION OF INDIA & ANR 414 W.P.(C) 5304/2016 M/S CHEMONIX INDIA PVT LTD VS.

UNION OF INDIA & ANR 415 W.P.(C) 5305/2016 SAI TECH MEDICARE PRIVATE LIMITED VS.

UNION OF INDIA & ANR 416 W.P.(C) 5306/2016 SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED VS.

UNION OF INDIA & ANR 417 W.P.(C) 5307/2016 SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED VS.

UNION OF INDIA & ANR 418 W.P.(C) 5308/2016 SAI TECH MEDICARE PRIVATE LIMITED VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 28 of 31 419 W.P.(C) 5309/2016 SAI TECH MEDICARE PRIVATE LIMITED VS.

UNION OF INDIA & ANR 420 W.P.(C) 5310/2016 SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED VS.

                                                 UNION OF INDIA & ANR
421          W.P.(C)                  SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED
            5311/2016                                     VS.\
                                                 UNION OF INDIA & ANR
422    W.P.(C) 5312/2016                 SAI TECH MEDICARE PRIVATE LIMITED
                                                          VS.
                                                 UNION OF INDIA & ANR
423     W.P.(C) 5313/2016             SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED
                                                          VS.
                                                 UNION OF INDIA & ANR
424    W.P.(C) 5314/2016              SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED
                                                          VS.
                                                 UNION OF INDIA & ANR
425    W.P.(C) 5315/2016                             M/S INTACTO
                                                          VS.
                                                 UNION OF INDIA & ANR
426     W.P.(C) 5317/2016             SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED
                                                          VS.
                                                 UNION OF INDIA & ANR
427     W.P.(C) 5318/2016             SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED
                                                          VS.
                                                 UNION OF INDIA & ANR
428    W.P.(C) 5319/2016              SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED

VS. UNION OF INDIA & ANR 429 W.P.(C) 5320/2016 SAI TECH MEDICARE PRIVATE LIMITED VS.

UNION OF INDIA & ANR 430 W.P.(C) 5321/2016 SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED VS.

UNION OF INDIA & ANR 431 W.P.(C) 5322/2016 SAI TECH MEDICARE PRIVATE LIMITED VS.

UNION OF INDIA & ANR 432 W.P.(C) 5323/2016 SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED VS.

UNION OF INDIA & ANR 433 W.P.(C) 5325/2016 M/S GROUP PHARMACEUTICALS LTD VS.

UNION OF INDIA & ANR 434 W.P.(C) 5332/2016 M/S ANPHAR ORGANICS PVT. LTD VS.

UNION OF INDIA W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 29 of 31 435 W.P.(C) 5334/2016 M/S COMBITIC GLOBAL CAPLET PVT. LTD.

VS.

UNION OF INDIA & ANR 436 W.P.(C) 5338/2016 SUPERMAX LABORATORIES VS.

UNION OF INDIA & ANR 437 W.P.(C) 5347/2016 M/S WINDLAS BIOTECH LIMITED & ANR VS.

UNION OF INDIA & ANR 438 W.P.(C) 5348/2016 M/S WINDLAS BIOTECH LIMITED ANR VS.

UNION OF INDIA & ANR 439 W.P.(C) 5349/2016 M/S WINDLAS BIOTECH LIMITED & ANR VS.

UNION OF INDIA & ANR 440 W.P.(C) 5355/2016 M/S. BAL PHARMA LIMITED VS.

UNION OF INDIA & ANR.

441 W.P.(C) 5364/2016 GOPISH PHARMA LIMITED VS.

UNION OF INDIA & ANR 442 W.P.(C) 5400/2016 SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED VS.

UNION OF INDIA & ANR 443 W.P.(C) 5402/2016 SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED VS.

UNION OF INDIA & ANR 444 W.P.(C) 5409/2016 SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED VS.

UNION OF INDIA & ANR 445 W.P.(C) 5410/2016 SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED VS.

UNION OF INDIA & ANR 446 W.P.(C) 5411/2016 SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED VS.

UNION OF INDIA & ANR 447 W.P.(C) 5412/2016 SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED VS.

UNION OF INDIA & ANR 448 W.P.(C) 5413/2016 SYMBIOSIS PHARMACEUTICAL PRIVATE LIMITED VS.

UNION OF INDIA & ANR 449 W.P.(C) 5429/2016 KARNANI PHARMACEUTICALS PVT LTD VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 30 of 31 450 W.P.(C) 5484/2016 M/S MERRIL PHARMA PVT LTD VS.

UNION OF INDIA & ANR 451 W.P.(C) 5486/2016 WOCKHARDT LIMITED & ORS VS.

UNION OF INDIA & ANR 452 W.P.(C) 5495/2016 KLAR SEHEN PVT LTD & ANR VS.

UNION OF INDIA & ANR 453 W.P.(C) 5507/2016 M/S AMBIC AAYURCHEM LTD VS.

UNION OF INDIA & ANR W.P.(C) No.2212/2016 & 453 other connected petitions as per Schedule Page 31 of 31

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