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the revised Schedule M, notified by the Ministry of Health and Family Welfare in December, 2023, has introduced a comprehensive and internationally accepted quality and documentation procedures and systems into the Indian pharmaceutical manufacturing context.
The revised standards were announced in the backdrop of serious questions raised against the quality and safety of medicines manufactured in the country, especially in the backdrop of the adverse events and deaths reported in countries like Gambia and Uzbekistan, in connection with the drugs manufactured in India.
The revised version has elaborated the scope of the norm from meagrely mentioning the Good Manufacturing Practices (GMP) to “Good Manufacturing Practices and requirements of premises, plant and equipment for pharmaceutical products”, and brought in systems such as the Pharmaceutical Quality System (PQS), Quality Risk Management, ensuring the quality of the materials used in production including water, ensuring quality of starting materials and restricting purchase of these materials only from approved suppliers, among others.
It also emphasises the requirement for documentation, stating that “Good documentation is an essential part of the quality assurance system and, as such, shall exist for all aspects of good manufacturing practices”. The Schedule bestows the onus of ensuring quality of the pharmaceutical products with the manufacturer, and puts in place various checks and balances for ensuring the same.
The standards, as well established, are on par with the international manufacturing quality standards, including the World Health Organisation’s (WHO) GMP. It also clarifies that the manufacturing premises shall be used exclusively for production of drugs and no other manufacturing activity shall be undertaken therein.
Regulatory experts are of the view that the revised form of the Schedule covers a larger area of drugs and pharmaceuticals manufacturing in order to ensure the quality and safety of the products, which is a commendable feat from the authorities to ensure the safety of patients in the country.
MSMEs voice concern
However, the manufacturers, at least the micro, small and some of the medium entrepreneurs, find several flaws in the plan, especially related to the practicality of some of these mandates and regarding the implementation of the standards.
For instance, the Schedule M stipulates that the water used in the manufacture of pharmaceutical products shall be suitable for its intended use and there shall be validated system for treatment of water drawn from own or any other source to render it potable in accordance with the standards specified by the Bureau of Indian Standards and Local Municipality.
“About 90 per cent samples of drinking water are not potable. Super pills are sought to be produced using the same water and have to be taken with the same water which is cause of 80 per cent disease,” says Jagdeep Singh, President, Punjab Drug Manufacturers Association (PDMA).
Lack of adequate qualified manpower skilled to execute the works in tandem with the revised Schedule M, including documentation of the procedures, is another challenge that could impact the implementation of the standards within the timeline.
“Before employing, industry cannot teach B. Pharm students as to what are the fractions of a Meter, pH and Factor calculation of molecules etc. This is taught in schools. But 19 out of 20 B. Pharm pass outs have no knowledge about it,” says the Association. There is also a shortage of unskilled manpower, it added.
The MSME units both in the erstwhile tax haven states and those in other States are finding it difficult to fund the investments required to comply with the revised standards. The industry complains that the financial support offered through some of the schemes by the Department of Pharmaceuticals, through technology upgradation funds and others, are also not helping.
They also fear that the strict implementation of the revised standards would end up in closure of thousands of manufacturing units, thus having a negative impact on the price of drugs available in the market. Hence, the industry has sought that the MSMEs need 3-5 years to upgrade with the handholding of the government.
The safety of the drugs is also dependent on the quality of the ingredients used in the manufacturing process. While the revised Schedule M elaborates on the requirement to ensure quality of key starting materials, active ingredients and others during storage, handling and manufacturing, some experts point out that there has to be more to ensure the quality of excipients, especially those which are imported from other sources.
This is also critical in ensuring the quality of medicines, and the quality issues with the cough syrups exported to Gambia and other countries is a case in point, they argue.
Regulatory mechanism
Another critical point is the ability of the regulatory mechanism in the country to continuously monitor the standards and ensure the adherence of the standards by industries across the country for a long period. It may be noted that many of the State drug regulatory offices are constrained with limited manpower for inspections and control.
The central licensing authority also may require a larger manpower to handle the matters, especially if the inspections are to be conducted as joint inspection with the central and state regulators jointly conducting the procedures. It may be noted that the compliance of Schedule M is a continuous process and the regulators has to monitor and inspect the facilities periodically to ensure compliance, even though the responsibility of adherence to the quality standards lies with the manufacturer.
A positive step
Many of the experts have welcomed these revisions, recognizing them as a positive step toward elevating quality standards and reinforcing the industry’s reputation. They believe that the updated regulations will promote the manufacturing of safe, effective, and high-quality drugs, aligning India’s pharmaceutical sector with global standards.
The revised Schedule M introduces significant enhancements to GMP in India’s pharmaceutical industry. These updates aim to align domestic standards with international benchmarks, ensuring the production of high-quality and safe pharmaceutical products, they point out.
The revised Schedule M represents a significant advancement in India’s pharmaceutical regulatory framework, emphasizing quality assurance, risk management, and compliance with international GMP standards. Pharmaceutical manufacturers are encouraged to adapt promptly to these changes to ensure the continued production of high-quality and safe pharmaceutical products.
While many of these factors could be teething troubles for both the regulators and the industry, the important aspect is that the standards and its implementation should not be watered down over a period of time, owing to various factors including the challenges in continuous implementation and monitoring, and policy and regulatory changes, they opined.
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