FDC ISSUE IN SUPREME COURT

P A Francis
Wednesday, November 15, 2017, 08:00 Hrs [IST]

The Centre’s decision to withdraw irrational and harmful combination drugs from the market continues to be entangled in courts with no early solution in sight. The DCGI banned 344 Fixed Dose Combination drugs covering 6000 brands on March 10, 2016 citing health risks for patients and lack of therapeutic justification in marketing them. Soon after this, the Delhi High Court stayed the Centre's order on March 14, 2016 on 454 petitions filed by several Indian and foreign drug makers challenging the validity of the ban. Subsequently, in December 2016, the Delhi HC quashed the Centre’s order banning the 344 FDCs. In January this year, the Centre filed an appeal against the December 2016 ruling of the Delhi High Court quashing the March 2016 notification of the government. During the hearings at the Delhi HC, the government has been maintaining the stand that the ban was in public interest as the combination drugs were not safe for health and have been banned in several countries. But the drug companies argued that the government did not properly implement the powers under section 26A (power to prohibit manufacture of drugs and cosmetics in public interest) of Drugs & Cosmetics Act, under which the ban was ordered. Now, the Supreme Court came into the scene and stayed the proceedings relating to 344 FDCs going on in Delhi and other high courts in March this year to bring an end to this court battle between drug companies and the government. Supreme Court then directed Union government and the respondent pharma companies last month to submit within two weeks the list of FDCs in three categories to enable the Court to take a final decision on the matter.

In the whole issue, the government stand has been that FDCs are new drugs and that makes it mandatory on the companies to conduct clinical trials and obtain marketing approvals from DCGI. But, most of these licenses were issued by State Licensing Authorities without obtaining any clinical trials by the companies. A large number of these 344 combinations are cough syrups and other OTC products requiring no prescriptions. The list of these products also has combinations of drugs like nimesulide, cisapride and PPA which have been banned in many countries years ago. Medical practitioners who rarely take note of periodical regulatory reviews of FDCs in the market have been promoting these products to their patients for several years. The DCGI decided to ban these drugs as it felt that the long term use of these products is likely to cause serious risk to patients especially when safer alternatives are available in the market. And the decision to ban these drugs was based on the recommendations of an expert committee constituted by the Health Ministry. Now, it is going to be two years in next March after the ban order was issued by the DCGI. How soon the matter will be decided by the apex court and whether there will be further appeals against the Supreme Court order are something one has to wait and see. But, what is increasingly becoming clear is that a government order in public interest cannot be easily implemented if it affects the interests of the corporates in the country.

In the last two decades with rise in infective disorders and osteoarthritis there are several FDC and OTC formulations which are dumped by number of Indian and MNC pharma companies which are recommended by chemist without doctor's recommendation.The most recent decision of supreme court which is suspended because of stay issued by high court on petition filled by Indian and MNCs regarding the decision of putting ban on irrational and harmful comvinations marketed of nimesulide,cough syrup and OTC brands is a logical decison in favour of public interest.

Its quite obvious that the FDC formulations which are irrational should mandatorily perform clinical trials proving its long term efficacy and safety and submit to DCGI for getting its approval for marketing in India. The available combinations doesn't have approval of DCGI,but they are approved by state licensing authority without any clinical trials,While supreme Court had issued withdrawal notice for same combinati