Last Updated on July 2, 2023 by The Health Master
Demand for 3 months time to Withdraw Recently Banned FDCs
The Tamil Nadu Pharma Traders Association (TN PTA), representing 30,000 pharmaceutical wholesalers and retailers across the state’s 30 districts, has approached the director-in-charge of the drugs control administration (DCA).
They have requested the Drugs Technical Advisory Board (DTAB) and the Drugs Consultative Committee (DCC) under the Union Health Ministry to grant a three-month extension for the withdrawal of 14 fixed dose combination (FDC) drugs recently banned from the market.
TN PTA Seeks Time to Comply with Ban:
Reasonable Timeframe Requested:
The TN PTA supports the central government’s decision to ban the use of certain drugs and acknowledges the importance of public safety.
However, they have requested a 90-day timeframe to sensitize their members and inform the medical community about the ban.
This time would enable them to effectively communicate the matter to doctors and raise awareness among the stakeholders.
Basis for the Ban:
The government’s decision to ban these 14 FDCs was made based on the recommendation of an expert committee.
The committee found that these combination drugs lacked therapeutic relevance and subsequently issued a notification on June 2.
Statutory Period of Notice:
Referring to a Delhi High Court order from December 2016, which nullified a previous notification banning 344 FDCs in March of the same year, TN PTA has urged the TN DCA to inform the Union government about the mandatory three-month statutory period before withdrawing products from the market.
They assert that this period is in accordance with Section 26A of the Drugs and Cosmetics Act.
TN PTA’s Actions and Concerns:
The president of TN PTA, also the owner of Janaki Pharmacy at Adyar, has forwarded the association’s request to the Union Health Minister and the Drug Controller General of India (DCGI), seeking immediate intervention.
The traders are facing challenges from online and discount chain pharmacies, and the sudden ban without prior notice has put them in a difficult situation.
Views from AIOCD:
Rajiv Singhal, the national secretary of the All India Organization of Chemists and Druggists (AIOCD), states that it is not the traders’ responsibility to approach the government or court seeking a timeframe for withdrawal of FDCs.
Traders are obligated to follow government directions. If a timeframe is necessary or public awareness needs to be raised, it is the duty of the manufacturers to seek relief through the legal system.
Upholding Government Decision:
Singhal emphasizes that the association is not involved in such matters since the government thoroughly evaluates all aspects before making decisions. Traders must comply with these decisions as they are made in the best interest of the public.
The TN PTA has appealed to the relevant authorities for a three-month extension to withdraw the recently banned combination drugs.
They are committed to supporting the government’s decision for the welfare of the public.
Meanwhile, the AIOCD suggests that it is the manufacturers’ responsibility to approach the government or court if they require a timeframe for withdrawal or wish to raise awareness about the ban.
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