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Industry urges health ministry not to make GMP guidelines mandatory under Schedule M

Laxmi Yadav, Mumbai
Monday, July 20, 2020, 08:00 Hrs  [IST]

Concerned over incorporation of strict WHO, ICH guidelines in the proposed revision of Schedule M, the pharmaceutical industry in the country has urged the Union health ministry to revise the Schedule M with minimum rules and back it up with detailed good manufacturing practice (GMP) guidelines separately in line with the global practices.

The industry representatives made the appeal on July 16, 2020 at a consultation meeting called by the ministry on finalization of draft Rule GSR 999 (E) dated October 5, 2018 to revise Schedule M as per World Health Organisation (WHO)-GMP standards. The ministry had published draft rules to amend GMP listed in Schedule M. The draft rules aim to bring India’s extant GMP on par with the WHO-GMP. Currently, 1,000 drug units out of 8,500 drug units in the country are WHO-GMP compliant. 300 plants are US FDA compliant.

Majority of Indian drug manufacturers comply with the extant GMP, however, less than 15% of manufacturers are WHO-GMP compliant, leading to dual standards of quality. The proposal to revise the GMP is in line with the Indian government’s goal of joining the Pharmaceutical Inspection Cooperation Scheme (PICS), a global mechanism to improve cooperation in GMPs between regulators.

SM Mudda, chairman, regulatory affairs committee, Indian Drug Manufacturers' Association (IDMA) said, “IDMA welcomes the move of the government to upgrade the Schedule M in line with the globally followed guidelines.”

He, however, pointed out that the proposed notification includes guidelines in the form of mandatory requirements. The guidelines help in the interpretation of the principles of GMPs and cannot be considered as legal requirements. The mandatory nature of Schedule M makes compliance with every provision a legal requirement and encourages enforcement approach. As a result, unfortunately, even a bona fide and unintentional non-compliance of any of the provisions under the Drugs and Cosmetics Act and Rules is considered as an offence exposing the manufacturers/dealers to legal actions.

IDMA has made a comprehensive representation to distinguish the principles of GMPs from the guidelines proposed to be included in Schedule M, in line with the framework adopted by global regulators. The EU framework has Directives and Regulations that are mandatory in nature and include the Principles of GMPs. These are supported by GMP Guidelines, for the interpretation and implementation of the principles, which are not mandatory requirements.

He emphasised the need for a serious and active review with the industry stakeholders before introducing any changes to the provisions of the D&C Act and Rules to make such changes beneficial to the patients while making them easy to comply with by the industry since the industry is highly technical and knowledge-based.

The requirements of GMP shall be amended to include the principles and concepts in the D&C Act & Rules, while the details shall be in the form of guidelines and advisories. The guidelines shall be dynamic and may be updated as per the prevailing situations and developments. The power to issue the guidelines and changes shall be with DCGI, he added.

This framework will encourage all sectors, including MSME, to comply with the upgraded GMP requirements, said Mudda. He cautioned that the implementation of the proposed Schedule M in the current format will lead to serious issues of interpretation and compliance and consequently will hamper the growth of the industry.

“IDMA agrees with the government that there is a need to upgrade GMP. However, IDMA has expressed the opinion that the new revision of Schedule M must have minimal rules, but should be backed up with detailed GMP guidelines. The elaborate guidelines on each aspect must be published as guidelines instead of rules, in line with international practices,” Said Viranchi Shah, senior vice president, IDMA.

Taking exception to the proposed revision of Schedule M making GMP requirements mandatory, Dr Rajesh Gupta, president of Himachal Drug Manufacturers Association and all India head, Laghu Udyog Bharati (pharma wing) said, “The GMP guidelines are never made part of any legislation world over. We are making WHO-GMP guidelines rules, its compliance will be very challenging for the industry and a number of MSMEs will be in big trouble. 4,200 drug units are MSMEs out of 8,500 drug units in the country.

He said, “The aim of the amendment to Schedule M is to enhance capabilities of domestic drug makers and boost our exports. For this, the proposed amendment to Schedule M is unwarranted. The existing GMP guidelines listed in Schedule M are effective in boosting efficiency of domestic industry. Considering divergent regulatory norms of importing countries, revision of GMP at par with WHO-GMP standards hardly warrants. The exporters dealing with CIS countries and Asian markets will only be benefitted from the revised GMP guidelines. Those looking to export US, European Union, UK, Australia, South Africa etc need regulatory approvals from US FDA, EMA, MHRA, TGA, MCC respectively.”

“The existing GMP guidelines listed in Schedule M came into effect from July 1, 2005. Schedule M protocols have been revised to harmonize it along the lines of WHO and US-FDA protocols. These revised protocols include detailed specifications on infrastructure and premises, environmental safety and health measures, production and operation controls, quality control and assurance and stability and validation studies. Ensuring compliance of the revised GMP guidelines is needed rather than making WHO-GMP guidelines rules. Training programmes need to be conducted to sensitize the drugmakers on compliance of existing GMP guidelines,” he added.

“We welcome the revision of GMP guidelines as long as it is being implemented as guidelines,” said Dr Gupta.











WHO, ICH guidelines, Schedule M, Union health ministry, GMP, US FDA, PICS, IDMA, Drugs and Cosmetics Act, D&C Act, Himachal Drug Manufacturers Association, Laghu Udyog Bharati, MSMEs, EMA, MHRA, TGA, MCC

“The existing GMP guidelines listed in Schedule M came into effect from July 1, 2005. Schedule M protocols have been revised to harmonize it along the lines of WHO and US-FDA protocols. These revised protocols include detailed specifications on infrastructure and premises, environmental safety and health measures, production and operation controls, quality control and assurance and stability and validation studies. Ensuring compliance of the revised GMP guidelines is needed rather than making WHO-GMP guidelines rules. Training programmes need to be conducted to sensitize the drugmakers on compliance of existing GMP guidelines,” he added.

“We welcome the revision of GMP guidelines as long as it is being implemented as guidelines,” said Dr Gupta.

 

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