Punjab-Haryana High Court
Navneet Kapoor vs State Of Punjab And Others on 4 December, 2012
Bench: A.K. Sikri, Rakesh Kumar Jain
CWP No.18723 of 2009 (O&M) -1-
IN THE HIGH COURT OF PUNJAB AND HARYANA AT
CHANDIGARH
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CWP No.18723 of 2009 (O&M)
Date of Decision: 04.12.2012
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Navneet Kapoor
. . . .Petitioner
Versus
State of Punjab and others
. . . . Respondents
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CORAM: HON'BLE MR.JUSTICE A.K. SIKRI, CHIEF JUSTICE
HON'BLE MR.JUSTICE RAKESH KUMAR JAIN
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Present: Mr.T.S. Sangha, Sr. Advocate, (Amicus Curiae) with
Mr.J.S. Lalli, Advocate,
for the petitioner.
Mr.J.S. Puri, Addl. A.G. Punjab.
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RAKESH KUMAR JAIN, J.
A complaint was made by the petitioner to this Court against the department of Police and Health in the State of Punjab for promoting business of drug mafia by issuing illegal drug licence on the basis of fictitious documents in lieu of illegal gratification. It is alleged that there are 259 wholesale medical shops as against 260 retail medical shops in the city of Moga where only 10% of the wholesalers are enough to cater the needs of the retailers. It is also alleged that 80% of the shops are being run without any Pharmacist. The shopkeepers are selling intoxicants and spurious medicines after getting issued the licence on the basis of fictitious documents. He thus prayed for CWP No.18723 of 2009 (O&M) -2- an appropriate direction in this regard by treating his complaint as Public Interest Litigation.
The complaint was not itself treated as Public Interest Litigation rather it was placed before the learned Single Judge of this Court to suggest the way out to deal with the complaint.
The learned Single Judge suggested that since the complainant has time and again referred to the information allegedly received by him under the Right to Information Act, 2005 from the offices of the (i) Director General of Police, Punjab;
(ii) Deputy Inspector General of Police, Ferozepur and (iii) various Government Offices at the District level, especially at Moga and Ferozepur, the matter may be investigated by deputing District & Sessions Judge (Vigilance), Punjab or Haryana, asking the complainant to produce material, if any, to substantiate the allegations and if the learned District Judge finds some substance in the allegations, then only the representation along with the preliminary report may be registered and entertained as a Public Interest Litigation on judicial side.
Apropos, the enquiry was conducted by the District & Sessions Judge-cum-Registrar (Vigilance), Punjab, who vide his report dated 03.12.2009 observed that "from the above facts, it is evidence that the material produced by the petitioner shows substance in the allegations and his petition deserves to be registered and entertained as Public Interest Litigation on judicial side in order to check drug mafia and mushrooming of chemists CWP No.18723 of 2009 (O&M) -3- shops under wholesale and ratail-holders of the licence, as there is likelihood of spurt in the menace of supply of the prohibited medicines without prescription and formation of Committee by the Government how to supervise the grant of licences without restricting the numbers or to amend the rules which were framed more than 60 years ago".
As a result of the aforesaid report, the complaint was treated as Public Interest Litigation and notice was issued on 7.12.2009.
Since, there was no-one on behalf of the complainant to pursue the matter and assist the Court, therefore, vide order dated 12.1.2010 request was made to Mr.Tejinder Singh Sangha, learned Senior Advocate to act as amicus curiae. The order reads as under:
"The learned District and Session Judge (Vigilance) Pu8njab in his report dated 30.11.2009 has concluded that the whole sale licence dealers are more than the retail chemist shop licence holders. For obtaining whole sale licence a person should either be a diploma holder in pharmacy or if he is matriculate then he should have four years experience. In case he is a graduate then he should possess one CWP No.18723 of 2009 (O&M) -4- year experience in the sale of medicines as provided by Rule 64 of the Drugs and Cosmetics Rules, 1945. The report reveals that there are 32000 retail outlets in Punjab and 8000-10000 wholesale outlets. The mechanism to check the menace of supply of prohibited medicines without prescription and their use by the youth of the society is posing a grave threat to the future generation. The gullible public is falling within the trap of drug mafia in the hope of making quick money. In order to streamline the supply of prohibited medicines being used as drug by the young generation particularly in Punjab, we deem it necessary that assistance of a Senior counsel is imperative. Accordingly, we request Shri Tejinder Singh Sangha, learned Senior Advocate to act as amicus curiae.
A complete paper book alongwith the documents and copies of the order be served on Shri Sangha.CWP No.18723 of 2009 (O&M) -5-
The matter be now listed for further hearing on 25.2.2010."
The State of Punjab filed its reply through Bhag Singh, State Drugs Controlling and Licensing Authority, Punjab alongwith guidelines for grant of wholesale and retail drug licences (Annexure R-1). After the receipt of reply by respondent No.1 along with new guidelines for grant of wholesale and retail drug licences dated 24.4.2010 (Annexure R-1), learned amicus curiae also submitted suggestions in writing seeking the intervention of the Court to direct the respondents to issue new licenses as well as to renew the existing licenses as per the new guidelines for grant of wholesale and retail drug licences dated 24.4.2010 (Annexure R-1). Besides, some other suggestions were also given. After some pleadings were produced on record, a comprehensive order was passed by this Court on 16.12.2010, which reads as under:
"We have heard learned Amicus Curiae as well as learned Addl. A.G. Punjab and have also perused the guidelines framed on 24.4.2010 (Annexure R-1) for grant of wholesale and retail drug licences, which have been attached with the affidavit dated 28.4.2010. The first problem confronted with this litigation is that there is hardly any check on the CWP No.18723 of 2009 (O&M) -6- sale of Scheduled-H and Scheduled-X drugs as detailed in those schedules appended with Drugs & Cosmetic Rules, 1945, (for brevity 'the Rules'), which cannot be sold without prescription of a Registered medical Practitioner. We have been apprised that the sale of these drugs is unabated in the State of Punjab even without any prescription slip of a Registered Medical Practitioner although under the Rules, there are various checks imposed on the chemist like maintenance of register etc. Accordingly, the Principal Secretary, (Health), Punjab, is directed to file a status report and the steps taken in that direction.
We have perused the guidelines (Annexure R-1) framed by the Principal Secretary, (Health) and we find that these guidelines are not inconsistent with the provisions of Drugs & Cosmetics Act, 1940 (for brevity 'the Act') and the Rules framed thereunder. It has been pointed out by the learned CWP No.18723 of 2009 (O&M) -7- Amicus Curiae that in para 9 of the guidelines, norm for granting licence in rural area has been provided but no such norm has been fixed in respect of urban area. Therefore, Principal Secretary, (Health) may incorporate additional guidelines fixing a norm for urban area as well as then shall consider the implementation of those guidelines.
Under Sections 5 and 7 of the Act, the Central Government is obliged to constitute a Drugs Technical Advisory Board comprising of number of persons like the Director General of Health Services, the Drugs controller, India, Director of the Central Drugs Laboratory, Calcutta, etc. Likewise, under Section 7 of the Act, the Drugs Consultative Committee are required to be constituted to advise the Central Government and the State Government and also the Drugs Technical Advisory Board on any other matter tending to secure uniformity throughout the CWP No.18723 of 2009 (O&M) -8- country for implementation of this Act. The Union of India, Ministry of Health & Family Welfare, New Delhi was made party-respondent in this Public Interest Litigation vide order dated 5.5.2010 and directions were issued on 20.5.2010 to file affidavit with regard to objection raised by the State of Punjab. The aforesaid directions have not been complied with. Therefore, we direct the Union of India to comply with the directions issued on 20.5.2010 and also to file status report with regard to Drugs Technical Advisory Board and the Drugs consultative Committee and the decision taken by them in the direction of controlling sale of scheduled drugs, so as to control the menace of drugs in the society effectively without compromising the availability of medicines to the public. An affidavit to the effect shall be filed a wek before the adjourned date.
The Principal Secretary (Health), Punjab may also consider the possibility of CWP No.18723 of 2009 (O&M) -9- taking steps for creating an enforcement wing, which may be attached with the Drugs Inspector or other officers of the Health Department who are empowered to control the sale of drugs generally particularly the scheduled drugs specified in Scheduled H and X of the Rules.
Let status report be filed a week before the adjourned date by the State of Punjab as well.
List again on 14.2.2011.
A copy of this order be given to learned State counsel as well as Amicus Curiae under the signatures of the Bench Secretary."
During the course of hearing, a reply dated 3.5.2011 was filed by Assistant Drugs Controller, Punjab, in which it was pointed out that a letter has already been sent to the Government of India, Department of Health and Family Welfare under Section 26A of the Drugs and Cosmetic Act, 1940 with regard to ban of medicines containing salt namely Diphenoxylate but nothing has been done so far. It was pointed out that the said drug was used for medical use in diarrhoea, and there is hardly any prescription CWP No.18723 of 2009 (O&M) - 10 - of this drug as more effective drug Loperamide with less side effects is being prescribed by the doctors for this purpose. It was alleged that it is a habit forming drug and have a clear potential for drug abuse which can be easily stopped because other anti- diarrhoeal drugs are available in the market.
After the receipt of status report by the respondent/department, another detailed order was passed on 29.2.2012, which reads as follows:
"This matter pertains to controlling the unabated and indiscriminate sale of drugs in this part of the country. In pursuance of direction, issued by this court, the State of Punjab has framed comprehensive guidelines on 24.4.2010 (R-1) concerning the policy for the wholesale and retail drug licenses. A detailed order in that regard was passed on 16.12.2010. Thereafter, affidavit by Shri Bhag Singh, State Drugs Controlling Authority, Punjab, was filed and details of district-wise work done report under the provisions of Drugs & Cosmetic Act, 1940 (for brevity 'the Act') and Drugs & Cosmetic Rules, 1945 (for brevity 'the Rules') CWP No.18723 of 2009 (O&M) - 11 - covering the period from 1.1.2005 to 31.7.2010 was given. It includes the status of inspection of the premises of the licensee holder and the details of action initiated against them. A perusal of the report concerning District Amritsar shows that there were as many as 23 cancellation of licences during the aforesaid period and prosecution was launched against 30 licensee. Likewise, the details are available in respect of District Bathinda, Barnala, Fatehgarh Sahib, Faridkot, Ferozepur, Gurdaspur, Hoshiarpur, Jalandhar, Kapurthala, Ludhiana, Moga, Mansa, Muktsar, Mohali, Nawanshahar, Patiala, Ropar, Sangrur and Tarn Taran and the prosecution was launched against the licensee. The details of prosecution, launched against the licensee, is also available (R-2). However, the status with regard to implementation of guidelines issued on 24.4.2010 has not been filed because these guidelines reflect a paradigm CWP No.18723 of 2009 (O&M) - 12 - major policy shift on the part of the State of Punjab and we fell that it would bring effective changes in controlling the indiscriminate sale of drugs in the State. Accordingly, we would require the respondent-State to file the status of renewal of licenses and implementation of various other guidelines as to whether the number of wholesale licenses has been reduced and the ratio of whole-seller/retailers which was mentioned in various parts of the guidelines has been maintained or not. It may also be pointed out that what is the result of steps taken with regard to habit-forming-drugs which were indicated in the affidavit of Shri Ajay Singla, Assistant Drugs Controller, Punjab.
Another issue which has been engaging the attention of this Court concerns either banning of certain habit-forming-drugs or to effectively regulate their sale by drug manufacturers in large quantity to the CWP No.18723 of 2009 (O&M) - 13 - distributors who further sell these drugs to the wholesalers in large quantity. We have been apprised that the wholesaler further sell the medicines to retailer. A letter to this effect has been addressed by the State of Punjab to the Ministry of Heath and Family Welfare, New Delhi on 11.11.2008 (R-1) suggesting that in order to control the illegal sale of drugs, the following amendments in the provisions of the Act and the Rules may be made: -
(1) Amendment in Rule 65(9) of the Drugs and Cosmetics Rules, 1965 for the supply of medicine containing narcotics drugs in the formulations to the Drugs Licenses also against the signed written order of the Drugs Licenses.
(2) Amendment in Rule 65(9) for fixing possession limit of retail sale drugs licenses for medicines containing CWP No.18723 of 2009 (O&M) - 14 - narcotics drugs in formulation.
(3) To issue notification under Section 26A of the Drugs and Cosmetics Act, 1940 for ban of salt Diphenoxylate and its preparation which are widely misused as intoxicants and which are least being used for therapeutic purpose.
(4) Detailed note regarding these proposed amendments is attached herewith.
In pursuance to the aforesaid suggestion, no effective steps appeared to have been taken except filing of the status report which was taken on record on 12.10.2011. According to the aforesaid status report the proposal to amend the Act and the Rules was considered by the Drugs Consultative Committee which is constituted under Section 7 of the Act in its 41st meeting held on 28.10.2010 at New Delhi. CWP No.18723 of 2009 (O&M) - 15 - According to the recommendation made a new Schedule has been suggested to be incorporated under the Rules as Scheduled HX which should include antibiotics, certain habit forming drugs which are commonly misused and other categories of drugs like anti-TB drugs. The recommendations further are that such drugs should be sold on double prescriptions where one copy of the prescription is to be retained by the chemist for one year. This will help in auditing the sale of such drugs. The container of these medicines should also be labelled with the following clause:
"Schedule HX drug - dangerous to take this preparation except in accordance with medical advice- Not to be sold by retail without the prescription of a Registered Medical Practitioner."
The proposal also listed 13 drugs under the list concerning habit-forming-drugs or those drugs having potential to CWP No.18723 of 2009 (O&M) - 16 - misuse have also been proposed to be included in the new Schedule. The names of such drug is as under:
1. Codeine
2. Dextroropoxyphene
3. Diphenoxylate
4. Propoxyphene
5. Nitrazepam
6. Pentazocine
7. Buprenorphine
8. Alprazolam
9. Midazolam
10. Zolpidem
11. Diazepam
12. Chlordiazepoxide
13. Tramadol The Committee while referring to Section 33 of the Act suggested that the notification in the official Gazette has to be published inviting objections and thereafter the amendment or addition shall be made under the Rules. No status report regarding the CWP No.18723 of 2009 (O&M) - 17 - recommendations made by the Committee has been placed on record.
Mr.M.S. Cheema, learned counsel for Union of India-Ministry of Health & Family Welfare states that the status report shall be filed within four weeks with copy in advance to the learned Amicus Curiae.
Let the status report in respect of the policy guidelines dated 24.4.2010 be also filed by the State of Punjab within four weeks.
List again on 3.4.2012.
A copy of this order be given to the learned counsel for the parties under signatures of the Bench Secretary."
In pursuance of the aforesaid order status report dated 27.3.2012 of the State Drug Controlling Authority, Punjab, was filed. It transpired from Annexure R-1 that number of wholesale drug licences were progressively decreased as in the year 2009-2010, 871 wholesale drug licences were issued but licenses issued in respect of period from 1.5.2010 to 31.3.2011 were 269 and for the period commencing from 1.4.2011 to 29.2.2012 it has further reduced to 129. Similarly, the trend CWP No.18723 of 2009 (O&M) - 18 - available in respect of the retail-sale drug licences (Annexure R-II) shows decrease in the issuance of licences.
Learned counsel for Union of India also placed on record a draft notification dated 20.3.2012 inviting comments to new Schedule namely HI and significant amendment was suggested in Schedule H. The Court found that as per the recommendations made by the Drugs Consultative Committee in its 41st meeting held on 28.10.2010 all the drugs which have been added in Schedule HX which were to be sold on double prescriptions where one copy of the prescription would be retained by the Chemist for one year for the purpose of audit. Since those recommendations were not taken care of in the draft rules, the Ministry of Health and Family Welfare of Government of India was asked to show cause as to why direction be not issued for incorporating those recommendations made by Drug Consultative Committee in the first meeting held on 28.10.2010 with regard to double prescription.
It is pertinent to mention that a specific affidavit was filed by K. Bangarurajan, Deputy Drug Controller (India) dated 30.8.2012 in which it was alleged that the Drugs and Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs and cosmetics in the country. The Act provides for the Constitution of the Drugs Technical Advisory Board (DTAB) under Section 5 to advise the Central Government and the State Governments on technical matters arising out of the CWP No.18723 of 2009 (O&M) - 19 - administration of the Act. The Act further provides under Section 7 for the constitution of 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 matters tending to secure uniformity throughout India in the administration of the Act. It is also alleged that as per Section 33 of the said Act, the Central Government has the power to make rules and after consultation with or on the recommendation of the Board (DTAB) and after previous publication by notification in the official gazette make rules for the purpose of giving effect to the provisions of this Chapter. It is also alleged that a meeting of the Drugs Consultative Committee, a statutory body under the Drugs and Cosmetics Act, was held on 28.10.2010. During the course of the meeting an agenda item to regulate sale of antibiotics more stringently in the country was considered. The members agreed that anti-microbial resistance because of indiscriminate use of antibiotics is increasing in the country and its sale should be separately regulated. It was further opined that certain other categories like anti-TB drugs and habit forming drugs which are commonly misused should also be included alongwith the antibiotics in separate Schedule and be named as Schedule HX. These drugs should be sold on double prescriptions where one copy of the prescription is to be retained by the chemist for one year which would help in auditing the sale of such drugs and the CWP No.18723 of 2009 (O&M) - 20 - container of the medicine shall be labelled with clause "dangerous to take this preparation except in accordance with medical advice- Not to be sold by retail without the prescription of a Registered medical Practitioner." It is also alleged in the affidavit that before the process of amendment of the Drugs and Cosmetics Rules, 1945 could be undertaken, numerous representations were received by the answering respondent from the stakeholders including chemist associations, etc. requesting to have a fresh look on the proposed amendment. Through these representations, issues regarding access to medicines and cost of care including issues relating to enforcement mechanism were raised. In the light of these representations, it was felt necessary to take a fresh look on the recommendations of the DCC. It was, therefore, considered that in order to bring prescription and use into sharp focus and attention, it was proposed to exclude all antibiotics, anti-TB drugs and certain habit forming drugs from the existing Schedule HX and put them in a separate Schedule called VH1 stipulating that the container of substance specified in Schedule H1 will be labelled with the symbol Rx and conspicuously displayed on the left corner of the label with the warning as mentioned above. It is also averred that the answering respondent on 20.3.2012 has issued a draft notification GSR 228(E) inviting comments of all persons likely to be affected on the proposed amendment of Schedule H1 of the Drugs and Cosmetics Rules, 1945 within a period of 45 days from the date CWP No.18723 of 2009 (O&M) - 21 - on which the copies of the Gazette of India containing these drafts rules are made available to the public and that all the comments received during the said period would be taken into consideration before finalizing the amendment. Ultimately, it was prayed that the writ petition be disposed of.
We have meticulously considered the pleadings and the efforts made by the respondents who have not only issued new guidelines namely Annexure R-1 but also the number of wholesalers and retail Chemists in the State of Punjab has been drastically reduced and Government of India is making all efforts to bring amendment after inviting objections. We hope and trust that the needful shall be done within three months, if already not done so.
Since the writ petition filed in public interest has served its purpose, therefore, the same is hereby disposed of but before that we place on record our appreciation for the assistance provided to the Court by Amicus Curiae Mr.T.S. Sangha, Sr. Advocate.
(A.K. SIKRI) (RAKESH KUMAR JAIN)
CHIEF JUSTICE JUDGE
DECEMBER 04, 2012
Vivek