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.

Earlier, the government's technical advisory board on drugs, which is part of CDSCO, had approved taking swift action against such manufacturers.

"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.