The Union Ministry of Health has banned the manufacture, sale or distribution of as many as 328 varieties of combination drugs in its efforts to keep a check on the irrational use of fixed-dose combination (FDC) medicines. The move will likely affect over 6,000 medicine brands worth about Rs 25,000 crore across the country. The FDC medicines are two or more drugs contained in a single dosage form. They are manufactured to evade price control measures and are low-cost drugs that can treat multiple diseases. The move was taken considering the larger public interest, says a government statement, adding that it will help curb the wrong use of ‘unsafe’ FDC medicines. Reports suggest the health ministry took the decision to ban these drugs after the Drugs Technical Advisor Board suggested these drugs might pose health risks.
With the ban, popular drugs like Saridon (painkiller), Gluconorm PG (used for diabetes), Lupidiclox (antibiotic), etc, will be no more in the sale.
Experts believe combination drugs to be unsafe because unaware physicians can prescribe the wrong dosage that can, in turn, make the human body resistant to treatment. India’s overall Rs 1.10-lakh crore drug market is saturated with over 25,000 brands. The government had initially brought in a notification to ban 345 combination drugs deemed ‘unsafe’ in 2010. Pharma companies and the government battled it out in various courts and eventually, the Supreme Court directed the government to set up another committee to take a fresh look. Thereafter, the issue was examined by the Drugs Technical Adviser to study its overall impacts.
“It is a good move by the government to ban combination drugs. It has been seen that there was no rational use of FDC medicines. Previously, in March 2010, the government had brought the notification to restrict about 344 categories of FDCs. However, it was challenged by various manufacturers in the court. In compliance with the directions given by the Supreme Court of India in its judgment dated December 15, 2017, the matter was examined by the Drugs Technical Advisory Board constituted under Section 5 of the Drugs and Cosmetics Act, 1940 and which furnished its report on these drugs to the central government,” Delhi’s Drug Controller Dr Atul Nasa told Mail Today.
Furnishing the report, the advisory board told the Ministry of Health there is “no therapeutic justification” for ingredients contained in these 328 FDC drugs. It has also pointed out about risks involved with these drugs with regards to human health. After considering the recommendations of the advisory panel, the government decided to ban these 328 FDC drugs in the larger public interest.