Last week, the Delhi High Court reserved its verdict in over 450 petitions filed by drug companies challenging the notification issued by Drugs Controller General of India on March 10 this year banning manufacturing and marketing of 344 fixed dose combinations. The High Court had on March 14 stayed the DCGI ban order on appeals from several large and small pharmaceutical companies and was hearing the cases since then. The drug companies had contended that government did not properly implement the Section 26A of the Drugs & Cosmetics Act under which the ban was ordered. DCGI’s 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 the fact is that most of these licenses were issued by State Licensing Authorities without conducting any clinical trials. 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 several years ago. Medical practitioners who rarely take note of periodical regulatory reviews of the authorities have been promoting these controversial products to their patients for several years.
The DCGI banned these drugs as it felt that the use of these products is likely to cause risk to patients when safer alternatives to them are available in the market. The decision to ban these drugs was based on the recommendations of an expert committee constituted by the Health Ministry. The committee was of the view that these FDCs have no therapeutic rationale to be in the market and needs to be banned. Marketing of thousands of FDCs is perhaps unique in India and does not exist in most of the developed and developing countries. This has been happening in India as the drug manufacturing licenses are issued by Licensing Authorities in every state and Union Territories. Most pharmaceutical companies take advantage of this situation and come up with ‘new products’ by combining two or more drugs claiming all kinds of therapeutic properties. Once manufacturing licenses are obtained from one state authority, the company can market such products all over the country. Now with the Delhi High Court’s action the government has the option to move the Supreme Court challenging the decision. What will be the final outcome of the long drawn judicial process in this matter is something to be seen. In the meanwhile manufacturing and sale of these doubtful products are on without any restrictions. What should not be forgotten in this context is the fact that the decision to ban these products was taken by an expert committee after seriously considering possible adverse effects of these combinations on the patients. Judicial incompetency in technical matters such as this should not be exploited by the responsible pharmaceutical companies just for commercial gains.