Fearing shutdown if the GMP deadline is not extended, 410 drug units

If the Central Government doesn’t extend the deadline for implementing updated good manufacturing procedures (GMP) within a year, up to 410 pharmaceutical micro, small, and medium-sized companies (MSME) would have to cease operations.

Companies with an annual revenue of more than Rs 250 crore are required to implement GMP within six months in order to guarantee the quality of their pharmaceuticals; small and medium-sized firms have a year to accomplish the same. Units will meet World Health Organization standards once these guidelines are adopted.

Individuals who disregard the changes may face penalties or have their licenses revoked. Following the Health Ministry’s December 28 announcement of the amended Schedule M of the Drugs and Cosmetics Act, the regulations went into effect.

Of the 665 pharmaceutical units in Himachal, 255 are accredited under the WHO-GMP, 255 have European Union-GMP, and many additional foreign certifications such as USFDA. By the end of December, the remaining 410 employees operating under the current Schedule M regulations are expected to upgrade in accordance with the enhanced GMP standards; failing to do so may result in closure.

“These 410 pharmaceutical units will have to shut since the new standards cannot be implemented in a year. Just the planning and design would take three months. Validation efforts will take three more months, even after the updated rules are adopted. It would take just six months to implement changes in a functioning unit with sufficient funding, according to Dr. Rajesh Gupta, head of the Himachal Drug Manufacturers Association.

“Units without sufficient funds will find it more difficult to arrange the necessary funds in a timely manner,” the speaker said.