Several pharma cos step up corrective action plans after crackdown by govt
In February 2023 Global Pharma Healthcare, a Chennai-based company Global Pharma Healthcare found itself in the spotlight of regulators when it was discovered that the US Centers for Disease Control and Prevention (CDC) issued warnings to customers using its eye drops that are sold on the American market, citing the possibility of contamination by bacteria. Nearly a year after Global Pharma Healthcare was granted the all-clear from the Indian Central Drugs Standard Control Organisation (CDSCO) in the wake of the quality inspections and corrective measures, as per government sources.
This isn’t a singular incident. Many pharmaceutical companies that came under the scrutiny of regulators as part of Government’s inspections based on risks throughout the country are slowly returning to normal following the implementation of corrective measures. For Andhra Pradesh, for instance seven companies were subject to suspension orders. Suspension orders for six of these companies have been removed and the seventh one is undergoing being lifted, sources with knowledge of the matter said to Business Standard.
The state of Tamil Nadu, authorities issued suspension orders to six businesses following the CDSCO launched a campaign to keep manufacturing practices that are not good under control. The objective was to make sure that companies follow the best manufacturing processes (GMP) standards. The most recent inspection was held in 2016-17.
The orders issued by the state are now revoked with the companies going through remedial action and prevention (CAPA) procedures.
“We issued a warning and they took corrective actions. This suspension was lifted following the implementation of CAPA was put into effect by the manufacturer,” said M N Sridhar who is the Director of the drug control department for Tamil Nadu. Six companies have been involved. actions against one was only partially lifted.
The move was initiated in the wake of an inspection by random sample of fixed dose mixtures (FDC) as well as syrups, vaccines and complex formulations, and bulk drug as well as other products from pharmaceutical companies. This was to check and confirm the manufacturing standards.
From the beginning of 2022, CDSCO has conducted risk-based inspections at numerous manufacturing facilities for pharma in India and in collaboration with the state drug control officers (SDCs). As of December 20, 2023, inspections had been conducted at 261 facilities in accordance with an Rajya Sabha response by Minister of State for Health Bharati Pawar.
The companies were identified on the basis of the risk factors, including the number of drugs listed as not being of good quality, complaints, and the importance of the product, Pawar said in her response. Based on the results of the inspections More than 200 actions such as the issue of show-cause notices and stop production orders as well as the removal and suspension of licenses are being initiated by State licensing agencies.
