TN PTA demands 3-month time to withdraw recently banned 14 FDCs from market

Monday, June 12, 2023

The Tamil Nadu Pharma Traders Association (TN PTA), a registered body of 30,000 pharmaceutical wholesalers and retailers working in the 30 districts of the state, has approached the director-in-charge of the drugs control administration (DCA) with a request to the DTAB and the DCC under the union health ministry to allow three months time for the traders to withdraw the recently banned 14 fixed dose combination (FDC) drugs from the market.

Stating that the chemist community is not against the decision of the central government for banning the drugs from use by people, TN PTA has informed the state regulatory body that they need a time-frame of 90 days to sensitize their members and to publicize the matter about the ban among the doctors’ community. The association said they support the decision of the government for the larger interest of the public.

The government banned the 14 FDCs on the recommendation of an expert committee which found the combination drugs lacked therapeutic relevance and issued a notification on June 2. Quoting a court order of the Delhi High Court of December 2016 quashing a notification by central government banning 344 FDCs in March in the same year, TN PTA has wanted the TN DCA that the department should inform the union government about the statutory period of three months prior to the withdrawal of the products from the market. The association says that there is a statutory period before issuing a notification of prohibition as per 26A of the Drugs and Cosmetics Act.
 
Communicating the traders’ issues with Pharmabiz, president of the TN PTA and owner of the Janaki Pharmacy at Adyar, said they have forwarded their demand to the Union health minister and to the drug controller general of India (DCGI) seeking immediate intervention. He said the traders are struggling in the midst of competitions from online pharmacies and discount chain pharmacies and in such a situation this decision of the government without any prior notice is putting the traders into quandary.
 
Meanwhile the national secretary of the pharmaceutical traders’ body AIOCD, Rajiv Singhal told Pharmabiz that it is not the duty of the traders to approach the government or any court of law seeking a time-frame for withdrawal of the FDCs as they are bound to follow the directions of the government. If time-frame is necessary for withdrawal of products or giving awareness to the public, it is the duty of the manufacturers of those medicines to approach the court of law for relief, he maintained.
 
“It is none of our business. The association has no obligation to look into it because the government has verified all aspects before announcing the decision and the traders have to follow it. If time is required for withdrawal it is the duty of the manufacturers to approach the government or the court of law. After all, the government has taken the decision for the public interest,” said Singhal.

PHARMABIZ.com