7 Baddi pharma units face 'stop manufacturing' order after inspection

Ambika Sharma

Solan, March 29

Seven pharmaceutical firms were told to stop manufacturing in various pharmaceutical clusters after they were found not complying with the laid manufacturing norms as enshrined in the Good Manufacturing Practices (GMP).

These laxities came to fore during joint inspections conducted by the officials of the Central Drugs Standards Control Organisation (CDSCO) and the state Drugs Department in the pharmaceutical firms since December 2022.

Teams, comprising officials of the Central Drugs Standards Control Organisation (CDSCO) and the state Drugs Department, have been inspecting the units located in the state’s pharmaceutical hub of Baddi-Barotiwala-Nalagarh, Paonta Sahib and Kala Amb.

The exercise, which began in December, was still continuing with 35 firms already having been inspected.

In a bid to identify potential hazards affecting the quality of drugs available to the common man, risk-based assessments are conducted from time-to-time in the pharmaceutical firms.

State Drugs Controller Navneet Marwaha said that the seven firms were issued stop manufacturing directions after certain shortcoming were found in the GMP compliance during the joint inspections. While six of them have complied with the laid norms, one manufacturer was upgrading the facility to meet the requisite norms.

It was known that critical observations like non-functional air handling units and dysfunctional lab equipment in the micro-labs located in these firms came to fore. Since they can adversely affect the quality of drug production, all such firms were issued directions to stop manufacturing till their systems were rectified.

Marwaha informed that they were routinely inspecting the drug firms and 3,000 firms have been inspected in the last three years where 43 were found non-compliant with the laid norms. He said their prime objective was to ensure quality drug manufacturing.

Apart from inspecting the mandatory compliance with the manufacturing and lab practises, the officials are also checking parameters such as the validation of machinery installed in the units. This would help ascertain the management’s seriousness in ensuring the quality of drugs.