New Delhi: The Ministry of Health and Family Welfare has imposed a ban on manufacture, sale and distribution of 328 fixed dose combination (FDC) drugs with immediate effect. The move come as a major blow to both country and foreign pharma companies.
The decision was made after the Drugs Technical Advisor Board (DTAB) suggested that these drugs might pose health risks.
The FDC medicines which are banned is a combination of two or more drugs that contained in a single dose form. They are manufactured to evade price control measures and are low cost drugs that can treat multiple diseases.
The move will likely affect over 6,000 medicine brands worth about Rs 25,000 crore across the country. With the ban, popular drugs including pain reliever Saridon, antibiotic Lupidiclox, skin care cream Panderm, antibacterial drug Taxim AZ and diabetes drug Gluconorm PG will be not available for sale.
Malini Aisola of the All India Drug Action Network have welcomed the government ban, saying it was a step towards addressing a “grave situation”. “The people of India have been made the consumers of unsafe medicines for too long,” she said.
Earlier, the Health Ministry had banned 350 fixed-dose combination drugs (FDCs) in 2016, which led to the legal battle between the ministry and the manufactures of these drugs. The battle went through several high courts and finally was taken up by the Supreme Court, last year.
Following this, an expert panel was formed by the Drugs Technical Advisory Board (DTAB). In its report to the Centre, the board stated that there was no therapeutic justification for the ingredients contained in 328 FDCs and that these combination drugs may involve risk to human beings.
The Board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in the larger public interest.
Considering the recommendations of DTAB and the expert committee, the Ministry of Health and Family Welfare, through a gazette notification, prohibited the FDCs.