Social Jurist, A Lawyer'S Group vs Union Of India (Uoi) And Ors.
2004 Latest Caselaw 249 Del

JUDGMENT

B.C. Patel, C.J.

1. On 20.2.2003, a Division Bench of this Court made an order as under in CM No.2116/2003:-

"Having heard learned counsel for the parties, we are of the view that NIMESULIDE and formulations containing NIMESULIDE deserves to be looked into by the Drug Technical Advisory Board as regards the safety aspect and also to see whether the same are duly approved or not, both for use by adults and children. In the light of what has been stated in the petition, we would like the Drug Technical Advisory Board to go into the entire aspect and submit a report. Learned Counsel for the respondent states that as per the mechanism evolved by the Supreme Court in Drug Action Forum & Others, WP [C] No.693/1993 decided on 23.2.2001, DTAB meets at least once in six months and the expert committee appointed by DTAB meets 5-6 times in a year. Accordingly, he states that at least three months time is required by DTAB to examine the whole issue and prepare its report. In case the petitioner so wants, he may submit material before the Expert Committee within a period of two weeks from today."

2. It appears that thereafter the matter was placed before the expert committee (DTAB). We have perused the names and and designations of the persons who participated in taking the decision and it appears that experts from various branches including Pharmacology were members of the DTAB. The DTAB has prepared a report. We reproduce the relevant part of the report as under:-

"The Chairman enquired whether members have received the material and have gone through it. The members replied in affirmative. Members Secretary also briefed the members about the details of the action taken by the Government in regard to examination of the rationality of formulations of Nimesulide which have already been furnished to the Hon'ble Court through an affidavit filed in the matter.

It was stated that the review of safety of Nimesulide and rationality of its combination formulations with Paracetamol etc. had been taken up by the Expert Committee (a Sub Committee fo DTAB) prior to the filing of the PIL. The Sub Committee in its meeting held on 9th October, 2002 considered the available literature on the drug, opinion of the AIIMS on its use, information available from ADR monitoring Centre at New Delhi and Lucknow etc. about any serious events reported at these centres. No report indicating casual relationship of any adverse event on the use of the drug was received. However, to generate further information on the drug, it was decided to obtain feedback on the use of the drug from leading Orthopedic surgeons, Gastroenterologists and Rheumatologists. The Indian Academy of Pedistrics (IAP) and Indian Medical Association (IMA) were also approached to elicit information from their members in the use of the drug. Casual relationship with serious liver toxicity or Reye's Sydrome, as alleged in media reports on the use of the drug, were not reported by any of these experts. The ADR centre at Victoria Hospital, Bangalore, which documented 200 ADRs due to various drugs since 2001 reported only 7 cases pertaining to Nimesulide and these were mostly skin related.

The Sub-Committee examined the feedback in its next meeting held on 10th December, 2002. It also took note of the reports which appeared in press about the use of the drug. The consensus view was that the evidences available so far does not indicate any casual relationship of the drug with the alleged adverse reactions. Importantly, the Delhi Society For Promotion of Rational Use of the Drugs has in its publication 'Standard Treatment Guideline 2002' (STG) recommended the use of Nimesulide Along with other drugs like ibuprofen and paracetamol for controlling fever in adults as well as children. The criteria for infusion of drugs in STG is based on overall safety, efficacy and cost effectiveness of drugs. The recommended dose in children is Tab / Syrp Nimesulide 5mg/kg/day.(sic) [5mg/ml/day].

For further information on the use of the drug in children, the IAP in addition to their earlier opinion about safety of the drug in children elicited response from various leading Pediatricians which attended an Indo-UK Symposium on February 1st and 2nd, 2003 at New Delhi. Most of the Experts opined that according to their experience with the drug there is no justification to ban the use of Nimesulide in children. However, the caution in regard to the use of the drug in any hepatotoxic condition or co-administration with other potentially hepatotoxic drugs should be provided Along with the medical literature or on the label. Some pediatricians suggested the dose of suspension may be further diluted. For this, Dr. S.K. Gupta, Head of Department of Pharmacology, AIIMS, New Delhi, was requested to give his expert opinion. He advised that 50mg/5ml suspension is a standard strength. Arbitrary change would not be scientific. For any reduced strength a further clinical study may be separately required.

The rationality of the formulations containing Nimesulide with Paracetamol or Muscle Relaxants was reviewed by the Sub Committee in its meeting held on 30th January, 2002, and the committee felt that as such, fixed dose combinations of NSAIDs like paracetamol, Diclofenec, ibuprofen and with Nimesulide have been in use for considerable period and well accepted. There are no reports of any adverse effects for these formulations which are mostly used on short term basis for relief from pain and inflammation. These formulations may be permitted to be continued. This opinion in respect of Nimesulide has already been provided to the Hon'ble Court.

The Member Secretary further explained that the drug was permitted for use in adults as well as children. Later, its sustained release formulations of 200 mg were also approved on the basis of data generated by the applicants and its due evaluation. However Nimesulide drops were not permitted by Drugs Controller, India.

Dr. Sanjiv Malik of IMA stated that the material furnished by the petitioners appears one sided and the facts have, in many instances, been projected in a distorted manner rather than on very scientific footing. Regulatory authorities of USA or UK never received the application for marketing the drug, so there is no question of the drug being prohibited or not approved in these countries. There are similar drugs like Analgin which have been used in many countries including India, but never used in USA, UK etc. He explained that due to various reasons and commercial viability etc. drugs marketed in one country may not be marketed in other countries. Use of Nimesulide was suspended only in 3 countries, though it is in use in about 50 countries. Israel has again permitted its use, after evaluating its overall safety data. No country has in the strict sense of the term (data missed) the drug. According to him the survey conducted by Indian Medical Association was extensive one and revealed that the drug is very useful and well accepted by medical community. Even the Indian Academy of Pediatrics have also endorsed the continued use of the drug in children. There is no overall evidence to suggest that its use should be prohibited.

He further added that to paint all these experts and professional bodies as having vested interest or lack sound knowledge just because they have not towed the stand taken by petitioners, is rather unfortunate.

Shri Adeshra opined that the drug should be permitted to be used for adults as well as children as an extensive evaluation of its benefit/risk ratio has been undertaken on scientific norms. However the use of the drug in form of drops be reviewed. Dr. Kokate and Dr. M.P. Yadav, Director, IVRI stated that the use of the drug in infants as drops may be reviewed and permitted only after its examination and approval by the office of Drugs Controller India.

After detailed deliberations, members opined that having considered the issues raised by the petitioner and the overall data on this drug, there is no ground for banning of drug Nimesulide for adult or pediatric use. The drug is considered to be as safe or unsafe as any other commonly used NSAID. The drug has dose convenience, as it is to be taken only twice a day and have lesser Gastero-intestinal irritation. It was noted that at the time of approval as new drug, it was approved to be sold against prescription of a Registered Medical Practitioner and this condition has not been withdrawn. However, the drug may be incorporated in Schedule-H which has not been revised for quite sometime. Number of other similar new drugs which are restricted to be sold against prescription at the time of first approval by office of DCG(I) but are yet to be formally brought under Schedule H, may also be simultaneously considered for inclusion in Schedule H.

The Board further recommended that manufacturers of Nimesulide drops should be asked, through respective State Licensing Authorities to stop the marketing of these formulations. In respect of formulations for pediatric use warning could be given on the label or the package insert indicating that co-administration with other potentially hepatotoxic drugs should be avoided, for the information of the consumers as well as Medical Community.

The members also agreed to the recommendation of the Sub-Committee that fixed dose combinations of Nimesulide with Paracetamol/Muscle Relaxants are like other similar combinations of NSAIDs for short time use and are considered rational, and may be permitted to continue to be marketed.

In regard to the approval of various Nimesulide formulations referred to by the petitioner, the Board observed that the prime responsibility of grant of manufacturing licenses rests with the State Governments and if the formulations are being marketed by the manufacturers under a valid license granted by the State Licensing Authorities, prima facie, these cannot be considered as illegal drugs. In this regard, the members examined in detail the prevailing scenario in the country. It was observed that while introducing the definition of new drug in a separate chapter under D & C Rules in 1988, the provisions under rule 69, 71 etc. in Part VII of the said Rules about approval of proprietary drugs by State Licensing Authorities remained the same. The State licensing authorities under these provisions continued to allow proprietary drug formulations. DTAB had taken a serious note of this situation. To avoid by-passing Drugs Controller India's approval in the case of grant of license for manufacture of such proprietary formulations which in strict sense may fall within the definition of 'new drugs' the Drugs & Cosmetics Rules were amended through the Gazette Notification GSR 311 (E) dated 01.05.2002 making it mandatory under Rules 69, 71 etc. for the State Licensing Authorities to ensure that the formulations falling under the definition of new drug, should have prior permission from DCI office. Therefore, it would be legally binding that further to 1/5/2002 the State Licensing Authorities should not grant licenses for manufacture of drugs falling under the definition of new drug without the prior approval of DCI and wherever such permission are granted after May, 2002, the same should be got withdrawn."

3. It is not for this Court to sit as an expert body and to render an opinion on such specialised fields such as safety of drugs. In view of report, the use of the drug in question in the form of drops be reviewed and be permitted only after its examination and approval by the office of the Drugs Controller, India. Suffice it to say that, in view of what the expert body (DTAB), after examining the matter, has stated in the report, we find that the allegations are not worth hearing further. Insofar as the other aspect of the matter, namely, persons manufacturing the drug without a valid license or authorisation or approval, is concerned, if a person is engaged in manufacturing activities in contravention of the provisions of the Drugs and Cosmetics Act, 1940, the competent authority can initiate action. If a Person is engaged in manufacturing activity and it amounts to an offence within the said Act, a prosecution can be launched under the provisions contained in the Drug and Cosmetics Act, 1940. It may be pertinent to note that earlier the prosecution could have been instituted only by an inspector but after the amendment which has come into force since 1986, any person aggrieved or a recognised consumer association whether such person is a member of that association or not also can initiate a prosecution. Therefore, it would be open for the petitioner or such persons to launch prosecution. We may however say at this stage that some of the manufacturers who are before us have produced copies of the licenses granted to them. The contention raised is that no approval was accorded. However, on the other side, on behalf of the UOI it is submitted that it is only after the requisite approvals that the licenses were granted. Anyhow, these are not the questions which we are required to examine and we are not expressing any opinion about the validity of the licenses etc.

4. It may be stated at this juncture that this Court took cognizance of the matter because of the alleged adverse effect of the drug on children. That issue has been cleared by the report of the DTAB. As regards the allegation that the manufacturing activities are contrary to the law, there is ample remedy available under the said Act.

5. After hearing the matter at length and reading the report of the committee, we are of the opinion that no further interference on our part is called for and the petition is disposed of accordingly.