The Union health ministry, early this month, approached Supreme Court, seeking to club and transfer all the petitions pending in various High Courts challenging the ministry’s order banning 344 fixed dose combinations issued in March this year.
The ministry's move is with the intention to avoid any kind of confusion on the issue that could arise from differing verdicts that may come from 10 High Courts including the Delhi High Court. In the Delhi HC, the case has already been heard and an order is expected any time. The ministry prohibited the 344 FDC drugs under Section 26 A of Drugs & Cosmetics Act as it felt that the use of these drugs is likely to cause risk to patients whereas safer alternatives to these FDCs are available in the market. The ban came into immediate effect and the affected pharmaceutical companies were to stop manufacturing and withdraw the stocks from the market. The wholesalers and retailers were also advised to not to sell the banned products. The ministry’s initiative was, however, defeated as several pharmaceutical companies approached various High Courts and got stay orders against the ban order.
The government's decision to ban these drugs was based on the recommendations of an expert committee constituted by the ministry. The committee was of the view that these FDCs have no therapeutic rationale to be in the market and needs to be banned. The ban order was certainly going to hit the revenues and profitability of pharmaceutical companies and trade as these products have been widely prescribed, promoted and often purchased without prescriptions for more than 20 years. 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 the product all over the country. DCGI has been advising state drug controllers for several years that the combination of two or more drugs should be treated as a new drug and marketing approval of DCGI needs to be obtained after clinical trials. Most of the SLAs have been ignoring this direction causing circulation of too many irrational combinations in the market. Now the health ministry’s recent move to club and transfer all cases pertaining to irrational combinations to Supreme Court should bring an early end to this unhealthy marketing practice in the country.