Karnataka based pharma companies like Embiotic Laboratories, Juggat Pharma and Anglo French have been granted interim relief by Karnataka High Court for the ban imposed by the Centre on sale of some of their fixed dose combination (FDC) drugs. Another manufacturer Ce Chem has confirmed that it has also got a stay through the Indian Drug Manufacturers Association which filed a plea in the High Court for its members. Micro Labs too said it got a respite for the FDC ban from the Delhi High Court. The directive from the Karnataka High Court for Embiotic Laboratories, Juggat Pharma and Anglo French stated, “The interim order however is subject to the condition that the petitioners shall inform all the distributors who would inform all the retail medical stores that sales of products mentioned under the impugned notification shall be sold only on prescription being issued by the prescribing doctors.” The drugs control department has now beefed up its surveillance on the manufacture-marketing and sale of 344 fixed dose combinations as per the recent government notification dated March 10, 2016 issued by the joint secretary, ministry of health and family welfare, government of India. The department has already circulated instructions to all pharma manufacturers in the state to stop the manufacture and sale of 344 fixed dose combinations as per the government order, said Sunil Attavar, president, Karnataka Drugs and Pharmaceutical Manufacturers Association. According to V Hari Krishnan, president, Bangalore District Druggists and Chemists Association and the Karnataka Chemists and Druggists Association, a circular from drugs control department has already circulated instructions to all pharma manufacturers and pharmacy trade outlets. The pharma industry has observed that the state regulatory authority has been extremely rigid in granting licenses for manufacture of FDCs and therefore much of these products are manufactured from locations outside the state.
The prohibition of FDC is good for India which is recognized as the pharmacy of the world. The fact is that globally 80 per cent of the drugs sold in the international markets are single ingredient formulations. This is a clear indication on the need to stop the sale of FDCs in India, noted pharma experts. Going by the considerable chaos and loss for the pharma industry, experts from the regulatory departments from the industry point out that government should have given at least a timeframe of six months prior to the ban. This would have given sufficient time for the industry to take remedial steps for product recall which includes discontinuing procurement of FDC raw materials, they said.