The Maharashtra State Chemists and Druggists Association (MSCDA) has urged the state Food and Drug Administration (FDA) to immediately stop the seizure of medicines from the market and to give appropriate time to the drug manufacturers to withdraw the products. Acting on the DCGI directive, the FDA had recently asked the drug manufacturers to withdraw such combination drugs which were mentioned in the DCGI list.
In a memorandum submitted to the state FDA Commissioner Dhanraj Kamatkar, MSCDA president Anil Navandar said that the FDA's order to the drug manufacturers to withdraw combination drugs from the market will create panic-like situation as there will be a huge shortage of medicines. "If all the listed combination drugs are withdrawn from the market, there will be panic in the state, especially when the state is under the siege of many monsoon-related diseases like viral fever," Navandar said.
The fixed dose combination issue is between the DCGI, state drug departments and the manufacturers. If the drug control department wants to withdraw some products, the department should give a certain period of time to the manufacturers and the traders. "We have no objection if the drug department wanted to withdraw some products from the market. But, there is a procedure for that. The drug department should give some time, say, 3 to 6 months," Navandar said.
Apart from creating panic in the state, the FDA's action will result in wastage of crore of rupees of medicines which are already in the market. The right procedure is to ask the manufacturers to stop production and approach the DCGI for license. Till the license is received, the medicines should be allowed to be in market, the MSCDA president said.
The MSCDA's concern comes in the wake of the state FDA's recent decision to issue notices to the drug manufacturers to immediately withdraw the listed products from the market within 15 days or face prosecution. Among the more than 1000 FDC brands listed by the DCGI, around 330 were licensed by the Maharashtra FDA.