Pharma units seek time till 2026 for implementing fresh norms
Tribune News Service
Solan, September 1
The state’s pharmaceutical units falling under the Micro Small and Medium Enterprises (MSME) category have sought three years’ extension for the implementation of the stipulations of the revised Schedule M norms of the Good Manufacturing Practices (GMP).
The compliance of these norms will bring the units on par with the World Health Organisation’s standards, which will help address issues related to the quality of drug production.
As per the notification issued by the Union Government in December 2023, the small and medium manufacturers have been given a year’s time to adopt the norms and its deadline expires in December 2024. Those failing to comply with the modifications will face suspension of their licence or a penalty.
“None of the MSME pharmaceutical units is capable of converting the MSME structure of 10,000 sq ft area to 50,000 sq ft within a year, where the requisite investment is to the tune of Rs 5-6 crore,” said Dr Rajesh Gupta, president of Himachal Drug Manufacturers Association (HDMA).
“Out of 655 units, 251 are GMP-certified while the remaining 404 units are to be upgraded to the stipulations of the revised Schedule M guidelines,” he said.
Though the Government of India has introduced a subsidy scheme, which provides up to Rs 1 crore for the upgrade of infrastructure and implementation of the WHO’s GMP, the investors said it was not possible to upgrade it within a year. An extension of three years had been sought from Union Health and Family Welfare Minister JP Nadda, said Gupta.
The association fears that it will lead to the closure of several small units. “Though the ministry had adopted global standards while amending the Schedule M, instead of introducing guidelines, they have incorporated a rule making it a more stringent provision,” said Gupta.
With a majority of the MSMEs already reeling under the liability of loans, availing additional loans will be time-consuming and cumbersome.
The manufacturers will be required to incorporate major changes such as introducing pharmaceutical quality system, ensuring quality risk management, reviewing quality of the product, validating the equipment, self-inspecting, along with approving suppliers audit and validating a GMP-related computerised system.
Issues such as inappropriate documentation, which include improper record of testing of drug batches, lack of maintenance of machinery, non-functional air handling units and dysfunctional lab equipment, lack of self-assessment, absence of internal product quality review, faulty designs of manufacturing and testing, etc., have been raised by the drug regulators in the risk-based assessments.
LICENCE SUSPENSION OR PENALTY
- As per the notification, small and medium manufacturers have been given a year’s time to adopt the norms. Those failing to comply with the modifications will face suspension of their licence or a penalty.
- “None of the MSME pharmaceutical units is capable of converting the MSME structure of 10,000 sq ft area to 50,000 sq ft within a year,” said Rajesh Gupta, president of Himachal Drug Manufacturers Association (HDMA)
