The Union Ministry of Health and Family Welfare, India (“MoHFW”), issued a notification on December 28, 2023, to amend and replace the current Schedule M of the Drugs Rules, 1945 (“Drugs Rules”), through the Drugs (Amendment) Rules, 2023 (“Amendment Rules”). The Amendment Rules were brought in to enhance quality controls for the manufacturing of pharmaceutical products, as there were many untoward international incidents of Indian-manufactured cough syrups and eye drops allegedly found to be spurious and contaminated. 1
The Drugs Rules outline the good manufacturing practices (“GMP”) for pharmaceutical manufacturing units, including detailed specifications for manufacturing premises, plant, and equipment under Schedule M. This schedule addresses the compliances to be undertaken during the manufacture, sale, and distribution of pharmaceutical products. However, the latest amendment to Schedule M under the Amendment Rules adopts a risk-assessment-based approach by introducing concepts such as pharmaceutical quality system (“PQS”), quality risk management (“QRM”), product quality review (“PQR”), qualification and validation of equipment, and a computerised storage system for all drug products to prioritise the quality of the products and eliminate any health risks arising due to manufacture of substandard pharmaceutical products.
This move is intended to bring the existing GMP requirements in line with global standards, particularly those of the World Health Organisation (“WHO”), and ensure the manufacture of drug products with globally acceptable quality. WHO defines GMP as “a part of a quality management system to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation.”2
The Indian government, recognising the need to bolster the credibility of Indian healthcare infrastructure globally, has strengthened the regulatory framework by introducing comprehensive, category-wise compliance requirements for 11 products. The following section highlights the significant concepts under the Amendment Rules:
(a) New Categories of Products
The Drug Rules consisted of the regulatory framework for 6 categories of pharmaceutical products: sterile products and parental preparations, oral solid dosage forms, oral liquids, topical products, metered dose inhalers, and active pharmaceutical ingredients. The Amendment Rules have introduced 5 additional categories of products, including hazardous substances such as sex hormones, steroids, or cytotoxic substances, biological products, radiopharmaceuticals, phytopharmaceuticals, and investigational pharmaceutical products for clinical trials for humans.
Unlike the erstwhile framework, where Schedule M was divided into 2 parts, the Amendment Rules now divide it into 13 parts. These include:
(b) Responsibility of the Manufacturer and Senior Management
The Amendment Rules have placed significant interest in ensuring the production of good quality, safe, and effective pharmaceutical products fit for their intended usage. The manufacturer of the pharmaceutical product will be responsible for the quality of the product. In addition, the Amendment Rules have also tied the responsibility for quality assurance to the senior management of manufacturing companies, where the senior management shall be ultimately responsible for attaining the quality objectives of the pharmaceutical products. They will need to oversee the setting up of quality management systems, implementing policies and defining the roles, responsibilities, and authorities of different departments. Under the Amendment Rules, the term ‘senior management’ is not specified; hence, a broad interpretation can be taken.
(c) Quality control systems
Quality management of a product includes a wide ambit of activities that may influence the quality of pharmaceutical products, including product design and development. The Amendment Rules have implemented the following critical systems to ensure the quality, safety, and efficacy of pharmaceutical products:
(d) Responsibilities of Manufacturers
The Amendment Rules impose a high level of responsibility on the manufacturers, including but not limited to the following:
The manufacturer shall:
(e) Revised thresholds and timelines
The Amendment Rules have indicated the statutory timelines for pharmaceutical companies to implement the new regulatory framework. Accordingly, large manufacturers with a turnover exceeding INR 250 crores are required to implement the Amendment Rules within 6 months from the date of publication. In contrast, small and medium manufacturers with a turnover of less than INR 250 crores have 12 months to effectuate the implementation.8
In the past, the absence of stringent quality checks and standards on manufacturing pharmaceutical products and compliance with the basic principles of GMP has had severe implications on public health, including safety and efficacy concerns resulting from substandard healthcare products. The Amendment Rules reflect a long-overdue reform aligning quality requirements with WHO-GMP levels. While the Amendment Rules will deliver promising results to consumers and consumer safety, they will place new responsibilities on mid- and small-pharmaceutical manufacturers, who will now need to account for potential cost and time overruns during the implementation phase.
[1] Available at: https://www.cnbctv18.com/healthcare/the-year-of-substandard-drugs-how-2023-saw-india-crackdown-on-poisonous-pharmaceuticals-18521411.htm
[2] https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/norms-and-standards-for-pharmaceuticals/guidelines/production
[3] Rule 1 of Part I of Schedule M of the Amendment Rules.
[4] Rule 2.1 of Part I of Schedule M of the Amendment Rules.
[5] Rule 2.3 of Part I of Schedule M of the Amendment Rules.
[6] Rule 5 of Part I of Schedule M of the Amendment Rules.
[7] Rule 20 of Part I of Schedule M of the Amendment Rules.
[8] Rule 6 of Part XIII of Schedule M of the Amendment Rules.
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