Introduction:

In a significant development for the Indian pharmaceutical industry, the union health ministry is considering a proposed amendment that will make good manufacturing practice (GMP) mandatory for all drug firms in the country. This move comes in response to recent scandals involving Indian-made drugs causing harm to children in foreign countries. By implementing these new regulations, the government aims to enhance manufacturing practices, ensure product quality, and regain trust in Indian-made medications.

Addressing Quality Concerns:

With Indian-made drugs failing quality checks in other countries, the need for a comprehensive solution became evident. The proposed amendment seeks to revise the existing manufacturing rules and bring all pharmaceutical companies in line with global GMP standards. Currently, only a small number of manufacturing units in India have the necessary GMP certification from the World Health Organization. Through this amendment, the government aims to enforce universal compliance, enhancing the overall quality and safety of Indian-made drugs.

Sensitizing Stakeholders and Ensuring Compliance:

The Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has taken proactive measures to sensitize industry stakeholders and drug firms regarding the new GMP regulations. Multiple meetings and workshops have been conducted with state drug controllers, educating them about the implementation of the revised schedule M of the Drugs and Cosmetics Rules. These interactions aim to address concerns and clarify queries raised by pharmaceutical companies. Furthermore, regional workshops and meetings have been organized across key cities in India to disseminate information and foster compliance with the upgraded GMP requirements.

Implementation Timeline and Industry Support:

To facilitate a smooth transition, the proposed amendment establishes a timeline for compliance. Large companies, with a turnover exceeding ₹250 crore, will have six months to adopt the enhanced GMP standards. Micro, small, and medium enterprises (MSMEs), with a turnover below ₹250 crore, will be given 12 months to comply with the regulations. Industry associations, such as the Indian Drugs Manufacturing Association (IDMA), have been actively involved, disseminating information and encouraging member companies to actively participate in discussions with the DCGI.

Conclusion:

The proposed amendment to mandate good manufacturing norms for all drug firms in India marks a significant step toward ensuring the quality and safety of Indian-made drugs. By making GMP mandatory for all pharmaceutical companies, the government aims to align Indian manufacturing practices with global standards. This move will help restore trust in Indian-made drugs, ensuring the well-being of both domestic and international patients. With sensitization workshops, support from industry associations, and a phased implementation timeline, the government is actively engaging stakeholders to drive compliance and facilitate a seamless transition to the upgraded GMP standards.

Disclaimer:

The information provided in this article is based on the latest Acts, Rules, Circulars, Notifications, Provisions, Press Releases, and other applicable material available at the time of compilation. We have diligently ensured the completeness and accuracy of the material. However, it is essential for users to consult the relevant legislation for specific guidance. Please note that the data provided may be subject to change without prior notice and should not be considered as professional advice. Estabizz Fintech holds no liability for any outcomes resulting from the use of this material.