The decision was taken after drug makers filed a petition, saying that these drugs were being manufactured since 1988. The petitioners cited the Supreme Court’s earlier relief to 15 manufacturers on the bases of the similar grounds, saying that they should also be exempted from the ban.
The Supreme Court also asked the Ministry of Health to give its opinion on the petitions filed against the order. The order provides a major relief to the companies like GlaxoSmithKline and Piramal, as these drugs are marketed by these companies.
The union ministry of health had banned the manufacture, sale or distribution of as many as 328 varieties of combination drugs manufactured in its efforts to keep a check on the irrational use of fixed dose combination (FDC) medicines. 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 SC order has affected over 6,000 medicine brands worth about Rs 25,000 crore across the country. Earlier, a government statement had said that the move would help curb the wrong use of ‘unsafe’ FDC medicines.
The health ministry had taken the decision to ban these drugs after the Drugs Technical Advisor Board suggested these drugs might pose health risks.
Experts believe combination drugs as unsafe because unaware physicians can sometimes prescribe a wrong dosage that can in turn make 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, which suggested the government to ban these 328 drugs.
Source: Business Today