CWP No. 8257 of 2004 [1] IN THE HIGH COURT OF PUNJAB & HARYANA AT CHANDIGARH CWP No. 8257 of 2004 Date of Decision: 04.10.2008 Prof. Dr. Ashi R.Sarin ..Petitioner versus Union of India and others ...Respondents CORAM: HON'BLE MR. JUSTICE T.S.THAKUR,CHIEF JUSTICE HON'BLE MR. JUSTICE SURYA KANT Present : Mr. A.K.Walia, Advocate for the petitioner Mr. Ashwinie Bansal, Advocate for Union of India Ms. Madhu Dayal, Addl. A.G. Punjab for respondent-State of Punjab ***** T.S.Thakur, C.J. (Oral) Petitioners in Civil Writ Petition No. 500 of 1997 filed in the Supreme Court of India, prayed for a mandamus directing respondents No.1 and 2 in that petition to initiate immediate steps to ban the use of Quinacrine in the form of pellets or otherwise as a method of sterilization. It also prays for a mandamus directing the respondents in the said petition to initiate proceedings under the Drugs and Cosmetics Act, 1945 against all those engaged in the importation, manufacture, transmission, sale and use of the said medicine in the form of pellets or otherwise as a method of sterilization. A mandamus directing the respondents to issue a Notification under Section 26-A of the Drugs and Cosmetic Act, 1945 banning the use of CWP No. 8257 of 2004 [2] Quinacrine as a method of sterilization was also prayed for. The said petition was, disposed of by the Supreme Court by an order dated March 16, 1998. A copy of the order passed by their Lordship has been placed on record as Annexure P-3 to this writ petition. A reading of that order would show that the same was based on an affidavit filed by Joint Director in the Directorate General of Health Services, inter-alia, stating that the respondents were taking steps to invoke the provisions of Sections 10-A and 26-A of the Drugs and Cosmetics Act, 1945 to prohibit/ban the import, manufacture, sale and distribution of Quinacrine in pellet form and for the use as a contraceptive. The counter affidavit further stated that draft notifications had already been prepared and submitted to the competent authority in the Ministry of Health and Family Welfare for approval. Copies of that notifications were also enclosed with the affidavit. Taking note of the said affidavit, the Supreme Court observed as under:- “ In view of the stand taken by the Central Government that it is taking steps to ban the import, manufacture, sale and distribution of the drug 'Quinacrine' for use as a method of non surgical sterilization on woman, no further orders are required to be made in this writ petition and we, therefore, consign the writ petition to records as disposed of.” Pursuant to the order mentioned above, the Government of India issued a Notification No. 499(E) dated 14.8.1998 under Section 26-A of the Drugs and Cosmetics Act, 1940 prohibiting the import, manufacture, transmission, sale and use of Quinacrine and its salts in any dosage form for female sterilization or contraception. The present writ petition that purports CWP No. 8257 of 2004 [3] to have been filed in public interest challenges the validity of the said notifications and prays for a certiorari quashing the same. The petitioner who happens to be a qualified Gynecologist having retired as Professor and Head Deptt. Of Obstetrics and Gynecology, Government Medical College, Patiala, asserts that the drug in question has been unfairly treated and wrongly prohibited from use, manufacture, sale or import as an ineffective drug for use for the purpose of female sterilization and contraception. When this writ petition came up before a Division Bench of this Court comprising D.K.Jain, Chief Justice as his lordship then was and Hemant Gupta, J. on 12.7.2005, a direction was issued to the Drug Controller of India to consider the representation which the petitioner was permitted to make and, to pass an appropriate order on the same within two weeks from the date of receipt thereof. The petitioner appears to have accordingly filed a representation, a copy whereof has been placed on record as Annexure R-2, addressed to the Drugs Controller General (India), Directorate General of Health Services, New Delhi. Upon consideration of the same, the Drugs Controller General (India) has by an order dated 5.8.2005, reaffirmed the view that the drug in question was a harmful drug as was revealed by the tests and trials conducted on different individuals for female sterilization or contraception. A reading of the order made by the Drugs Controller General, India further shows that Quinacrine has been under investigation for use as method of female sterilization since 1960. Investigators funded primarily by private individual and foundations have, however, produced limited scientific data to support the drug's efficacy or safety for tubal sterilization. The order further refers to the examination by the ICMR Expert Committee CWP No. 8257 of 2004 [4] in January, 1993 which after examining the technical data on the drug, recommended limited clinical trials to study the effect of two insertions of Quinacrine of 250 mg each and single insertion of 324 mg. Toxicological Review Panel of ICMR evaluated the clinical data obtained in a limited trial on 8 cases at two centers at Chandigarh and Baroda. The results of these trials were, however, not found satisfactory as out of 8 cases, three cases had failed. The ICMR had, therefore, discontinued the trial. The order also refers to the fact that notification in question had been issued by the Government of India on the recommendations of the Drugs Technical Advisory Board based on 46th meeting held on 01.12.1997. The said Board, it is noteworthy, is a statutory Board under the Drugs and Cosmetics Act, 1940 and is competent to advise the Government on technical matters arising out of the administration of the Act. The Director General has, based on all these facts, observed:- “ It is observed from the report published in 'Population Reports' referred to in your letter under point (4),it is observed that the article referred by you itself states that “ the safety of Quinacrine as sterilization method is still in question. FHI is currently conducting research, including toxicology studies, to determine whether intra-uterine use of Quinacrine poses a risk of cancer. Results from these studies are expected in 2007”. It has been further stated that some Women's rights groups have opposed Quinacrine on the ground that toxicology and animal studies did not precede clinical trials, which is the established research procedure; that CWP No. 8257 of 2004 [5] large scale clinical trials began before small safety studies were complete; and that in some placed women were not informed of its experimental nature or offered other contraceptives.” In the light of the above and the fact that the process of prohibition against the use of the drug in question has gone through trials and is based on opinions of the Experts placing reliance upon scientific data collected from time to time, we see no reason to declare the drug to be safe for use as a contraception or for female sterilization nor do we see any justification for striking down the notification by which the use of said drug has been banned. The question whether a particular drug is or is not safe for use by human beings, is a matter which would require not only Expert opinions to arrive at a correct conclusion, but also data based on scientific trials and experiments. In the absence of any material to conclusively prove that the drug is safe for female sterilization or contraception, it will be hazardous to make any pronouncement about its efficacy or to reintroduce the user thereof in exercise of judicial power, especially one in purported public interest under Article 226 of the Constitution of India. The proper course for the petitioner or even the companies engaged in the manufacture and marketing of the drug in question is to agitate the matter in the appropriate forum and to present material before the appropriate authorities to establish the safety and efficacy of the drug so that Scientists and Professors who use the drug are persuaded to accept the same as safe and efficacious. The Government can then be requested to introduce the drug again. So long as there is no material or contrary opinion conclusively establishing the safety or efficacy of the drug in question, we find it difficult CWP No. 8257 of 2004 [6] to issue a direction for reintroduction of the drug. There is no merit in this petition which fails and is hereby dismissed but in the circumstances, without any order as to costs. (T.S.THAKUR) CHIEF JUSTICE (SURYA KANT) 04.10.2008 JUDGE 'ravinder'