Several pharma cos step up corrective action plans after crackdown by govt

In February 2023, Chennai-based Global Pharma Healthcare found itself in the crosshairs of regulators after the US Centers for Disease Control and Prevention (CDC) issued a warning to consumers using its eye drops sold in the American market, citing potential bacterial contamination. Now, nearly a year later, the company has been given the all-clear by India’s Central Drugs Standard Control Organisation (CDSCO), following quality checks and corrective measures, according to government sources.

This isn't an isolated incident. Several pharmaceutical companies that faced regulatory scrutiny as part of the government's risk-based inspections across the country are gradually getting back on track after implementing corrective measures. In Andhra Pradesh, for instance, seven companies received suspension orders. Suspension orders to six of those companies have now been revoked while the last one is in the process of being lifted, sources close to the development told Business Standard.

In Tamil Nadu, authorities issued suspension orders to six companies after the CDSCO initiated a drive to keep poor manufacturing practices in check. The aim was to ensure that manufacturers adhere to the good manufacturing practices (GMP) norms. The last such inspection took place in 2016-17.

The orders in the state have now been revoked, with the companies undergoing corrective and preventive action (CAPA) processes. 

“We issued a notice and they took corrective action. The suspension order was revoked after CAPA was implemented by the manufacturers,” said M N Sridhar, joint director of drug control in Tamil Nadu. Of the six companies, action on one company has only been partially revoked.

The action was taken following the inspection of random samples of fixed-dose combinations (FDC), vaccines, syrups, complex formulations, and bulk drugs, among others, from manufacturers. This was to verify and validate manufacturing standards.

Since the end of 2022, the CDSCO has been conducting risk-based inspections at several pharma manufacturing sites in India, in collaboration with state drugs controllers (SDCs). By December 2023, inspections had been carried out at 261 premises, according to a Rajya Sabha response by Minister of State for Health Bharati Pawar.

The firms were identified based on risk criteria, such as the number of drugs declared as not of standard quality, complaints, and the criticality of the products, Pawar said in her response. Based on the findings of the inspections, more than 200 actions -- including the issuance of show-cause notices, stop production orders, and the suspension and cancellation of licences -- have been taken by state licensing authorities.

Last year, 17 firms in Himachal Pradesh were asked to cease manufacturing as they failed to meet stipulated norms. Baddi, a pharma manufacturing hub in Himachal, was particularly affected. In Gujarat too, around 15 product licences were cancelled from six pharma companies in April 2023.

State drug controllers in these states could not be reached for comments. However, industry sources estimate that around one-third of the affected firms have rectified the problems outlined.

Pharma firms are expected to comply with Schedule M of the Good Manufacturing Practices (GMP) under the Drugs and Cosmetics Rules, 1945.

"There are several MSMEs that flout these norms and are non-compliant. If these firms are weeded out of the manufacturing network, it is only going to be good for Indian pharma. But, there are several that are doing serious business, and they would take corrective steps,” said an industry insider. He further said that industry bodies regularly hold quality assurance and awareness creation meetings with stakeholders. "Last week there was a meeting in Pune which saw attendance of 700 firms and also officials from the drug regulator’s office."

Meanwhile, another source pointed out that at times there are lapses by global inspection bodies too. “In the case of one firm making sterile liquid products, the export consignment was opened for testing; seals were broken by a global inspection body. This tampered consignment was sent for testing, and the sterility of the products was found compromised,” said the source.