Baddi pharma units face inspection

Ambika Sharma

Tribune News Service

Solan,May 24

In a bid to ensure the quality and effectiveness of drugs made by pharmaceutical units, a team of officials from the Central Drugs Standard Control Organisation (CDSCO) started inspection of various pharmaceutical units in Baddi-Barotiwala-Nalagarh yesterday.

This inspection is part of the CDSCO’s “Risk-Based Inspection of the Pharma Manufacturing Facilities” across the nation and the exercise is supposed to be carried out in all states in a phased manner. Himachal was among Maharashtra, Tamil Nadu and Uttarakhand where such inspections are being held . Officials said various international regulators in the US and Europe had been raising concern over the lack of compliance of the globally accepted GMP norms by Indian companies. The CDSCO has, therefore, initiated a drive to tighten the noose around such units whose numerous products have been rejected by various international regulators.

An exporter based at Baddi said several issues pertaining to rejections from the US Food and Drug Administration involved data integration where data had been fudged by firms. He said 13,334 products were rejected from January 2010-December 2015 which was slightly less than China whose 15,087 products were rejected. This was a reflection on the lack of compliance of the GMP and Good Laboratory Practices by firms .

Officials are supposed to ensure that the manufacturing facilities setup by various pharmaceutical companies are complying with the provisions of the Good Manufacturing Facilities (GMP) as laid down in the Schedule M of Drugs and Cosmetics Rules, 1945.

A check list has been prepared by the regulatory enforcement agencies to ensure consistency and uniformity in the inspection process.

This check list is being used as a science-based tool. This list will also help the pharma industry in self-assessment of its existing facilities. CDSCO is also imparting training to drug regulators and analysts from the state and Centre for inspection of manufacturing units.

Drug Controller Navneet Marwaha said it would help in rectifying the deficiencies and ensure better compliance of the norms. Various pharma units in BBN, Parwanoo, Kala Amb and Paonta Sahib would be inspected by June 1.