India’s government is pushing pharmaceutical companies to adopt the Revised Good Manufacturing Practices (GMP). This measure aims to elevate local industry standards to be in line with global benchmarks. Companies with an annual turnover more than Rs 250 crore have a six-month deadline, while smaller firms with yearly turnover under Rs 250 crore should comply within a year.
Understanding Good Manufacturing Practices (GMP)
GMP is a system dedicated to ensuring products are regularly produced and regulated according to standardized quality metrics. It mitigates risks in pharmaceutical production that can’t be nullified by solely examining the final product. Major risks include unexpected contamination, health damage or death, incorrect labeling, and improper quantities of active ingredient leading to adverse outcomes.
The World Health Organization (WHO) has laid down extensive GMP guidelines. A number of countries have created their own GMP requirements based on these or decided to harmonize theirs similar to the Association of South-East Asian Nations (ASEAN), European Union and through the Pharmaceutical Inspection Convention.
GMP was first introduced into India in 1988 in the Drugs and Cosmetics Rules’ Schedule M, which last amended in June 2005. The updated Schedule M now comprises WHO-GMP norms.
Essential Changes in Modified GMP Guidelines
Pharmaceutical Quality System and Risk Management
The revised directions propose a pharmaceutical quality system, emphasizing a thorough quality management system throughout the manufacturing activity. Firms need to implement quality risk management strategies to identify potential threats to their product quality and take preventive measures. Regular quality inspections are required to maintain consistency.
Stability Studies
Companies must conduct stability studies considering climate conditions. It requires assessing drug stability over time by storing them in climate chambers under certain temperature and humidity levels. Accelerated stability tests may also be performed to evaluate the product’s stability under hasten conditions.
GMP-Related Computerized Systems
The updated guidelines stress the need for computerized systems to manage GMP-associated procedures. These systems prevent data manipulation, unauthorized access, and omission of data.
Investigational Products for Clinical Trials
The updated Schedule M also covers additional product types like biological products, radioactive agents, or plant-derived items. It specifies requirements for investigational items produced for clinical trials, guaranteeing they meet necessary safety and quality standards.
The Necessity for Updated GMP Guidelines
Alignment with Global Standards
Adopting the new norms would align the Indian industry with international standards.
Incidents of Contamination
There have been several reported contaminations in India-produced syrups, eye-drops, and ointments. Deaths linked to these products have been recorded in Gambia, Uzbekistan, US, and Cameroon.
Deficiencies in Current Practices
Risk-based inspections discovered numerous shortcomings in 162 Indian manufacturing units. Deficits include inadequate raw material testing, lack of product quality review, infrastructure issues and missing qualified professionals.
The introduction of elevated standards will assure that pharmaceutical companies adhere to standard processes, quality control measures, and avoid shortcuts, enhancing the quality of medicines both domestically and globally.
Confidence to Regulators from Other Countries
Enforcing uniform quality standards across the industry will increase trust among regulators from other countries. Additionally, it will enhance medicine quality in local markets.
India’s decision to enforce revised GMP norms signifies a significant step towards achieving global quality standards in the pharmaceutical industry. The updated standards aim to bolster quality control measures, proper documentation and IT support, thus ensuring the production of top-quality medicines in India and for the global market.
