Uttarakhand High Court
M/S Tridoss Laboratories Pvt. Ltd vs Drug Controller And Another on 2 September, 2022
Author: S.K.Mishra
Bench: Sanjaya Kumar Mishra
AFR
IN THE HIGH COURT OF UTTARAKHAND AT NAINITAL
Writ Petition (M/S) No.1145 of 2016
M/S Tridoss Laboratories Pvt. Ltd .......... Petitioner
versus
Drug Controller and another ......Respondents
Mr. V.K.Kohli, learned Senior Counsel assisted by Mr. Hari Mohan
Bhatia and Altaf Hussain, learned counsel for the writ applicant.
Mr. Yogesh Pandey, learned Additional Chief Standing Counsel,
assisted by Mr. Hargovind Pant, Brief Holder for the State.
Mr. V.K.Kaparwan, learned Standing Counsel for the Union
of India.
With
Writ Petition (M/S) No.277 of 2016
M/S G.S. Pharbutro .......... Petitioner
versus
Drug Controller General and others ......Respondents
Mr. Akhil Sibbal, learned Senior Advocate, assisted by Mr. Manpreet
Ahluwalia, Ms. Menka Tripathi, and Mr. Salil Seth, learned counsel for
the writ applicant.
Mr. Suyash Pant, learned Standing Counsel, assisted by Mr.
Hargovind Pant, Brief Holder for the State.
Mr. V.K.Kaparwan, learned Standing Counsel for the Union
of India.
And
Writ Petition (M/S) No.2072 of 2016
M/S Creative Healthcare Pvt. Ltd. .......... Petitioner
versus
The Drug Controller (Uttarakhand) and others
......Respondents
2
None appears for the petitioner.
Mr. Yogesh Pandey, learned Additional Chief Standing Counsel,
assisted by Mr. Hargovind Pant, Brief Holder for the State.
Mr. V.K.Kaparwan, learned Standing Counsel for the Union of India.
-----------
Date of Judgement: 02.09.2022
Hon'ble Sanjaya Kumar Mishra, J.
Upon hearing the learned counsels, the Court made the following Order.
1. In these three writ petitions, the petitioners have prayed for issuance of a writ of certiorari quashing the Circular dated 06.01.2016, issued by the Drug Controller General (India), i.e., respondent no. 1 and also to quash the letter dated 18.01.2016 issued by the Drug Controller of Uttarakhand, Directorate of Medical Health and Family Welfare, Dehradun, i.e., respondent no.3. These two circulars and order annexed as Annexure No. 1 & 2 with the writ petition bearing No. WPMS No 277 of 2016. A further prayer has been made to direct the respondents not to interfere in the manufacture and sale of the Povidone Iodine Ointment 10% weight by weight by the petitioner.
2. The petitioners in all the three Writ Petitions are Limited Companies duly incorporated under the Companies Act, 2013 and are engaged in manufacturing of Drugs in the State of Uttarakhand. Among other drugs, they also manufacture different compositions, wherein the Providone Iodine Ointment is used as 10% of the total volume of the Ointment/liquid.
33. It is the case of the petitioners that in the year 1972, the Central Drugs Standard Control Organization, which is a part of the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, approved Providone Iodine to be used as a ingredient containing 10% of the solution and Betadine Gargle containing 0.5% of the Providone Iodine. It also provided for Betadine Gargle Ointment containing 10 % of Providone Iodine. This approval has been granted by the Government of India in the month of November, 1972. However, on 06.01.2016, the Drugs Controller General of India, by virtue of Annexure-1, i.e. F. No. 04-01/2015-DC (Misc.62), directed all the State Licensing Authority that the licenses (Product Permission) granted in favour of the manufacturers to produce the Ointment containing Providone Iodine containing 10% weight/weight (W/W) be cancelled and all the ointments be recalled from the market. It is further seen from the aforesaid circulars that it was brought to the notice of the Directorate that the Firms were manufacturing Providone Iodine Ointment 10% W/W. The Drugs Controller General of India was, therefore, of the opinion that the ointment containing Providone Iodine Ointment 10% weight/weight is not yet approved by the State Directorate, and the said formulation falls under the category of "new drugs"
under Rule 122-B of the Drugs and Cosmetic Rules 1945. Therefore, the Controller General further directed that for its manufacture, all the applicants should submit Application Form-41 of the Drugs 4 and Cosmetic Rules to the Central Directorate with requisite fees along with necessary documents of grant of approval. The Central authority mentioned in the Circular that grant of license without permission from the Licensing Authority under Rule 21(b) of the DCG (I) is in contravention of the Drugs and Cosmetic Act and Rules made there under as well as it would be loss of revenue of the Central Government. Therefore, in the interest of public Health, the licensing authority of the all the State were requested to cancel license (product permission) and recall all the ointments from the market.
4. In developing the case of the petitioners, learned Senior Counsel Mr. Akhil Sibbal would submit that the Directorate of Drugs Control General of India committed an error by intimating the Licensing Authorities that the drugs have not been approved. In fact, it has been approved since November, 1972 and therefore, the impugned circular Annexure-1 to the writ application (lead case) and Annexure-2 (appearing at page 30 of the lead case), the recall order passed by the Drugs Controller of Uttarakhand are liable to be quashed.
5. In an additional affidavit, this aspect of the case has been brought to the notice of the Court and the said additional affidavit was filed prior to the filing of the counter affidavit.
56. In the counter affidavit, the Union of India, (internal page 6 of the counter para 2) has submitted as follows:
"The circular issued on 06.01.2016 for cancellation of product permission and recall of ointment containing Providone Iodine Ointment 10% w/w was based on the available records of Central Drugs Standard Control Organization as Providone Iodine Ointment 10% is not approved by CDSCO. As per records available with CDSCO, "Provide Iodine Solution 10% and Providone Iodine Ointment 10% were approved in 1972, However, unit i.e. w/w is not mentioned in the approval. Hence, manufacturing and marketing permission was required to be obtained from office of DCG(I) as per Rule 122B of the Drugs and Cosmetic Rules, 1945 prevalent before 19.03.2019, which is quoted as under:
Rule 122B: Application for approval to manufacture new durg[***] (1) (a) No new drug shall be manufactured for sale unless it is approved by the Licensing Authority as defined in clause (b) of rule 21.
(b) An application for grant of approval to manufacture the new drug and its formulations shall be made in Form 44 to the Licensing Authority as defined in clause (b) of rule 21 and shall be accompanied by a fee of fifty thousand rupees.
Provided that where the application is for permission to import a new drug (bulk drug substance) and grant of approval to manufacture its formulation/s, the fee to accompany such application shall be fifty thousand rupees only.
Provided further that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with new claims, is made, the fee to accompany such subsequent application shall be fifteen thousand rupees:
Provided further also that any application received after one year of the grant of approval for the manufacture 6 for sale of the new drug, shall be accompanied by a fee of fifteen thousand rupees an information and data as required by Appendix I or Appendix IA of Schedule Y, as the case may be.] (2) The manufacturer of a new drug under sub-rule (1) when applying for approval to the licensing authority mentioned in the said sub-rule, shall submit data as given in Appendix I to Schedule Y including the results of clinical trials carried out in the country in accordance with the guidelines specified in Schedule Y and submit the report of such clinical trials in the format given in Appendix II to the said Schedule. 3[(2A) The Licensing Authority as defined in clause (b) of rule 21 after being satisfied that the drug if approved to be manufacture as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, shall issue approval in Form 46 and/or Form 46A, as the case may be, subject to the conditions stated therein: Provided that the Licensing Authority shall, where the data provided or generated on the drug is inadequate, intimate the applicant in writing, and the conditions, which shall be satisfied before permission could be considered.] (3) When applying for approval to manufacture of a new drug under sub-rule (1) or its preparations to the State licensing authority an applicant shall produce along with his application, evidence that the drug for the manufacture of which application is made has already been approved 3[in the name of the applicant] by the licensing authority mentioned in rule 21:
Provided that the requirement of submitting the results of local clinical trials may not be necessary if the drug is of such a nature that the 4[Licensing Authority in Rule 21] may, in public interest decide to grant such permission on the basis of data available from other countries:
Provided further that the submission of requirements relating to Animal Toxicology, Reproduction studies, Teratogenic studies, Perinatal studies, Mutagenicity and Carcino-genicity may be modified or relaxed in case of new drugs approved and marketed for several years in other countries if he is satisfied that there is adequate published evidence regarding the safety of the drug, subject to the other provisions of these rules."
The formulation being marked without approval of DCG (I) (Licensing Authority under Rule 21 of the Drugs and Cosmetic Rules, 1945) is in contravention of Drugs and Cosmetic Act, 1940 and 7 Rules made there under as well as loss of revenue to the Central Government.
Rule 122E:
"122E Definition of new drug. --For the purpose of this part, new drug shall mean and include--
(a) A drug, as defined in the Act including bulk drugs substance which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognised as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims:
Provided that the limited use, if any, has been with the permission of the licensing authority.]
(b) A drug already approved by the licensing authority mentioned in rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration.
(c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz., indications dosage, dosage form (including sustained release dosage form) and route of administration.
( See items (b) and (c) of Appendix VI to Schedule Y). Explanation. --For the purpose of this rule--
[(i) all vaccines and Recombinant DNA (r-DNA) derived drugs shall be new drugs unless certified otherwise by the Licensing Authority under rule 21;]
(ii) a new drug shall continue to be considered as new drug for a period of four years from the date of its first approval[***]."
7. Learned Senior Counsel appearing for the respondent in this case would submit that the concerned Ministry in the Union of India has approved the use the Providone Iodine at 10 % since November, 1972, and the product Providone Iodine Ointment 10%(w/w) is being manufactured in India since 1972 and has been sold in the market. He would further submit that the mention of 10% in Providone Iodine to be used in solution of the 8 ointment cannot be read without a specific reference either to volume or to weight and the product mentioning 10% weight to weight Providone Iodine Ointment is in compliance of the Rules framed under the Drugs and Drugs and Cosmetics Act.
8. He would rely upon the sub-clause (iii) (e) of Sub Rule 1 of Rule 96 of the Drugs Rules, 1945, which is quoted below:
"The content of active ingredients--
This shall be expressed--
(a) for oral liquid preparations in terms of the content per single dose, the dose being indicated in 5 millilitres 6[***]:
Provided that where the dose is below 5 millilitres the contents of active ingredients may be expressed in terms of one millilitre 6[or fraction thereof];
[Provided further that where the single dose is more than 5 millilitre, the content of active ingredients shall be expressed in terms of minimum single dose as approved by the licensing authority,]
(b) for liquid parenteral preparations ready for administration, in terms of 1 millilitre or percentage by volume or per dose in the case of a single dose container:
Provided that if the preparation is contained in an ampoule it will be enough if the composition is shown on the label or wrapper affixed to any package in which such ampoule is issued for sale;
(c) for drugs in solid form intended for parenteral administration in terms of units or weight per milligramme or gramme;
(d) for tablets, capsules, pills and the like, in terms of the content in each tablet, capsule, pill or other unit, as the case may be;
(e) for other preparations, in terms of percentage by weight or volume or in terms of unitage per gram or millilitre as the case may be:
Provided that clause (ii) shall not apply to a pharmacopoeial preparation where the composition of such preparation is specified in the respective pharmacopoeia and to a preparation included in the National Formulary of India;"
Thus, it is contended by the learned senior counsel that even though the reference has not been made in the Notification of Approval issued in 9 November, 1972, it was the duty of the Manufacturer to level the product by giving the specification weight/weight and that such product the Betadene Gargle and Providone Iodine are not new drugs.
9. Learned Central Government Counsel Mr. V.K.Kaparwan would submit that since the original Notification of the ministry of Health and Family Welfare did not specify the standard weight/weight, the production and sale of such liquid or ointment specifying the volume of Providone Iodine would be a new drug, even though it has already been approved in the year 1972 in the month of November. It has been manufactured by many manufacturers and that the Circular issued by the Drugs Controller General that it would lead to loss of revenue and in Public Health is also not supported by cogent reasons. It is brought to the notice of the Court that for each product the drug manufacturers have to deposit Rs. 50,000/ for granting of license. So, there is not much loss of revenue in this case as only three players have come to the Court seeking quashing of the aforesaid Notifications.
10. Furthermore, interpretation under Section 122E of the Drugs and Cosmetics Act, 1945, which provides definition of a new drug, on a plain reading would lead to the following conclusion:
For the purpose of the Act, new drugs shall mean and include in clause (a) of the Act.
(a) of the Act-
(i) a new drug is, a drug including bulk drugs substance;10
(ii) which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the leveling and,
(iii) has not recognized as effective and safe by the licensing authority mentioned Or Clause (b) provides a Drug already approved by the Licensing Authority mentioned in rule 21 for certain claims, which is now proposed by market with modified or new claims, including, namely indications, dosage, dosage from (including sustained release dosage form and route of administration.
In clause (c)- a drug shall be a 'new drug' if it satisfies the following:-
(i) a fixed dose combination of two or more drugs,
(ii) individually approved earlier for certain claims, and
(iii) which are now proposed to be combined for the first time in a fixed ratio Or
(iv) if the ratio of intergradient has already been marketed, with certain new claims.
A plain reading of these ingredients provides in clause (a) that a new drug shall include a drug, including volk substances, which has not been used in the country to any significant extent and has not been recognized as an effective and safe by the licensing authority. This provision is not applicable to the present case. As Providone Iodine 10% is a drug which has already been used in the country for a significant extent in the leveling under conditions prescribed, recommended or suggesting in the leveling. Also, it has been recognized as an effective 11 and safe by the licensing authority. So, clause (a) of the aforesaid section shall not be applicable in the present case.
As far as clause (b) of the aforesaid provision is concerned, if a drug is already being used, but it is being prescribed for a different indications, in a different dose, including sustained release dose, and route of administration, which can be oral, external, intravenous or intramuscular, then it shall be a new drug. For example, a drug which is being used only for oral purposes, if used also for intravenous administration to patient then it will be a new drug. However, such is not the case here. The Drug Providone Iodine is being used only as a for the purpose of gargle and mouth wash.
Clause (C) provides for a case where to or more drugs which have already been approved for certain claims and there is a proposal of two combination of two or more drugs in a fixed ratio or a changed ratio for any particular indications dosage or dosages including sustain release and route of administration then it will be a new drug. This provision is, therefore, not applicable to the case in hand.
11. Furthermore, clause (e) of Sub Rule 96 of the Drugs Rules, 1945, provides that the content of active ingredients shall be expressed, for other preparations, in terms of percentage by weight or volume or in terms of units as per gram or millimeter as the case may be. Thus, in preparations involving in other preparation, not involving oral 12 liquid, liquid parental preparation, solid drugs, tablets etc., the drugs must be specified in terms of percentage by weight or volume. Thus, lebelling Providone Iodine 10% w/w is in consonance with the Rule prescribed under the Act. Unless the manufacturer follows this provision, he will be liable to be proceeded against. Thus, Providone Iodine 10% is not a new drug and the lebelling of it at 10% w/w does not make it a new drug.
12. As far as Public Health is concerned, it is not the case of the Union of India either in the Notification or in the Counter Affidavit that the drugs that is being manufactured by the petitioners are in any way dangerous for humane consumption. This Court particularly asked Mr. Kaparwan, learned counsel for the Central Government that if there is any apprehension in the mind of the Authorities that such drugs may be dangerous to human on consumption. However, though he says that it may be there in the mind of the authorities but he has not produced any authentic document or an authentic written instructions to that effect. It is also not disputed by anybody specifically by the State of Uttarakhand or the Union Government that any test was conducted with respect to the use of the said drugs in 10 % of the solution or ointment and it was found that it was found to dangerous to human being in any manner.
13. Another factual aspect, which has to be taken into consideration by this Court is the fact that the Ministry of Chemical and Fertilizers, Department, 13 the Pharmaceutical, Government of India, as per the order dated 8th November, 2019, has ordered, in exercise of powers conferred by para 4, 6, 10, 11, 14, 16, 17 and 18 of the Drugs Control Order 2013, read with SO 14349E dated 16th May, 2013 and SO 701E, dated 10th March, 2016, issued by the Government of India, Ministry of Chemical and Fertilizer, the National Pharmaceutical Authority, that the price of that drug shall be as specified in column no. 5 of the table therein.
14. Thus, it is clear that the Ministry of Chemical and Fertilizer considered this schedule formulation containing 10% of Probidone Iodine to be an essential drug whose price has to be controlled and, therefore, issued the notification which has been annexed to the Rejoinder Affidavit as RA No. 2. Through, learned counsel for the State as well as Union of India submitted that the purpose of Notification issued by the Ministry are different and the Notification issued by the Fertilizer and Chemical cannot be construed as a license to manufacture the same, we are of the opinion that since a very responsible view of the Government being the Ministry of Fertilizer and Chemical has considered that the prices of a formulation having 10% of Probidone Iodine have to be regulated and fixed the price at 5.09 Paisa per one gram. It shall be inappropriate to hold that this is a new drug and in any way dangerous for human consumption.
15. In that view of the matter, we find sufficient substance in the submissions made by the learned 14 Senior Counsel appearing for the parties and find merit in the Writ Applications. In that view of the matter, all the three Writ Applications are hereby allowed.
16. Thus, the Circular dated 06.01.2016, i.e., Annexure 1 to the lead case and the order/letter dated 18.01.2016, issued by the Drugs Controller of Uttarakhand, Directorate of Medical Health and Family Welfare, Dehradun (Annexure No.2), are hereby quashed and a Mandamus is issued commanding the respondents not to interfere in the sale of Probidone Iodine Ointment 10% w/w by the petitioners in these cases.
There shall be no orders as to costs.
(S.K.Mishra, J.) (Grant urgent copy of this order as per Rule) Kaushal