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Time of India
25-06-2025
- Health
- Time of India
Pharma companies may lose licence if drugs fail tests
Drugmakers will have to face strict government action if their products fail quality parameters and are declared as substandard. The punitive measure is being proposed by the health ministry during ongoing discussions with states to ensure quality drug production and safeguard public health. The ministry is looking to issue a notification shortly that will mandate immediate suspension of product licences of companies found producing 'not of standard quality' (NSQ) drugs by government laboratories, officials said. The Central Drugs Standard Control Organisation ( CDSCO ) on its part has been deliberating the matter with pharma lobby groups that have raised objections. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Victoria Principal Is Almost 75, See Her Now Reportingly Undo Earlier, the government's technical advisory board on drugs, which is part of CDSCO, had approved taking swift action against such manufacturers. Live Events "The board noted that it is very important that once a drug is declared NSQ, the license of such product shall be suspended immediately in public interest unless a satisfactory corrective action and preventive action (CAPA) is submitted by such manufactures. After detailed deliberation, DTAB recommended for the appropriate amendment in the Drug Rules in this regard and the suspension product licence should be revoked only after root cause analysis and corresponding CAPA has been implemented," according to the minutes of a board meeting of the technical advisory body. "The health ministry and the CDSCO is taking a step forward by taking views of the states and pharma bodies as it would require a notification," said a government official on the condition of anonymity. However, the pharma lobby groups have raised objections and given representations. NSQ, "is a global phenomenon, and most of the time, it is due to technical issues without any wrongful intent," the Federation of Pharma Entrepreneurs (FOPE) said in its representation. In a recent meeting, pharma lobby groups also pointed out that many government testing laboratories are facing challenges in following the current standards. "This has been a long-standing concern. It is also necessary that the NSQ investigation includes a review of records and data from government testing laboratories, as well as GLP compliance by the Drugs Inspector," a member of a lobby group opined. "It has been found that in many cases, samples declared NSQ by government labs, when challenged and tested by CDL Kolkata, have been declared as Standard Quality by CDL Kolkata, which is an appellate laboratory," the person said. Drug makers also emphasised that more than suspending licenses, it is crucial to strengthen the "recall mechanism". FOPE urged a proper impact analysis given the sensitivity of the matter. "We fear it may lead to malpractices in the profession, and genuine manufacturers with investments of hundreds of crores in plant setup, product development, technical team development, brand development, business development, and goodwill, may be adversely impacted if actions like the suspension of product permission are taken without proper investigation," the lobby group said.
Time of India
21-04-2025
- Business
- Time of India
Russia-Ukraine war: Indian pharma firm caught in crossfire, lobby seeks PM Modi's help
An Indian pharma company is caught in the Russian-Ukraine conflict zone, prompting a pharma lobby group to seek Prime Minister Narendra Modi's intervention. The Federation of Pharma Entrepreneurs ( FOPE ), which represents small and medium pharma companies, has written to the Prime Minister Office seeking a policy to protect assets of Indian companies abroad, particularly in war zones, days after a warehouse of Kusum Healthcare in Ukraine caught fire reportedly after a missile struck it. The fire has resulted in damages worth ₹150 crore, the federation said in its letter dated April 17. The FOPE requested the government "to come out with a policy to protect assets of Indian companies abroad" in a way the lives of Indian nationals are protected. The company supplies life-saving and critical medicines in the conflict zone, the federation said, and sought immediate payment of compensation to Kusum to help it maintain operations. The warehouse was situated in the eastern part of Kyiv. Russia dismissed accusations that its military attacked the warehouse. The Russian embassy in India suggested that a misfired Ukrainian air defence missile could have caused the damage, blaming Ukraine's "ineptly operated electronic warfare systems" for the incident. It said the Russian forces have "never targeted civilian facilities". A company executive said Kusum Healthcare is the biggest Indian company in Ukraine and is doing its best to arrange stocks of medicines for Alzheimer's and Parkinson's as well as other critical diseases. "The Government of India should intervene and take up the issue," he said on the condition of anonymity.
