The Supreme Court of India on Monday allowed the sale of popular combination drug Saridon and two other drugs after Health Ministry had banned 328 combination drugs last week. The Court’s order came when a petition was filed by a drug manufacturer challenging the health ministry’s order to ban FDCs manufactured before 1988. The Court had also sought centre’s reply over the same petition.
On one hand, when the decision of banning 328 Fixed-Dose Combination Drugs cheered by health activists who were worried about the growing antibiotic resistance due to the misuse of these medicines. On another hand, major pharma companies are challenging the Centre’s decision and claimed that the only reason given in the government’s notification was that combination drugs had no therapeutic value.
It may be recalled, the Health Ministry had on September 12 banned the manufacture, sale and distribution of 328 fixed-dose combinations (FDC) drugs, including painkiller Saridon with immediate effect, asserting that these drugs do not add to the benefits that people can get by taking them.
On Friday, the Delhi High Court had allowed Indian pharma major Wockhardt to sell till Tuesday (September 18) its anti-inflammatory medicine, which is among the 328 fixed-dose combinations (FDC) drugs banned by the Centre.
The government said, “The Drugs Technical Advisory Board recommended, amongst other things, that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings. The board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under Section 26A of the Drugs and Cosmetics Act, 1940, in the larger public interest.”
The move of banning 328 combinations drug was followed by a Supreme Court (SC) order in which the court had banned 15 drugs earlier this month. The 15 drugs, which include a cough and cold medicines Phensedryl and Tixylix, have a market size of over Rs 7 billion.
The Health Ministry had, through a notification of March 10, 2016, prohibited 349 FDCs for manufacture, sale and distribution under Section 26 A of the Drugs and Cosmetics Act, 1940. The notification was then contested by the pharma companies in the Delhi High Court and the Supreme Court.
Complying with the apex court direction, an expert panel set up by DTAB, in its report to the Centre, had stated that there was no therapeutic justification for the ingredients contained in 328 of the 349 FDCs, which may also involve risk to human lives.
Also read: India bans 328 FDC drugs including popular painkiller Saridon