Revised manufacturing rules for drug firms: what changes, and why

Source: The post is based on the article “Revised manufacturing rules for drug firms: what changes, and why”  published in Indian Express on 7th August 2023.

What is the News?

The Government of India has directed all pharmaceutical companies in the country to implement the revised Good Manufacturing Practices (GMP), bringing their processes at par with global standards.

What are Good Manufacturing Practices (GMP)?

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What is the need of these GMP Standards for pharmaceutical companies?

One, implementation of these GMP norms will bring the Indian industry on par with global standards.

Two, there have been a string of incidents where other countries have reported alleged contamination in India-manufactured syrups, eye-drops, and eye ointments. The deaths of Children in the Gambia, Uzbekistan and the United States have been linked to these products.

Three, a risk-based inspection of 162 manufacturing units by the government found several deficiencies — incoming raw materials not being tested before use, product quality not being reviewed , infrastructure deficiency to prevent cross-contamination, faulty design of manufacturing and testing areas, missing qualified professionals and poor documentation.

Fourth, GMP standards are also important as only 2,000 of the 10,500 drug manufacturing units in the country at present meet global standards being WHO-GMP certified.

Fifth, implementation of the revised good manufacturing practices (GMP) standards are also listed in the 2018 draft schedule M of the drugs and cosmetics rules.

What are the major changes GMP standards will bring?

The revised GMP guidelines focus on quality control measures, proper documentation, and IT backing to maintain quality of medicines produced.

It also introduces pharmaceutical quality systems, quality risk management, product quality review and validation of equipment. 

This will mean companies will have to carry out regular quality reviews of all its products, verify consistency of the quality and the processes, thorough investigation of any deviation or suspected defect and implementation of any preventive actions. 

It also suggests a change control system to evaluate all changes that may affect the production or quality of the product.

The guidelines also state that companies should have GMP-related computerized systems, which ensure that there is no tampering of data related to the processes.

How will these changes help?

Instituting the same quality across the industry will give confidence to regulators from other countries. In addition, it will improve the quality of drugs in the domestic markets.