Centre notifies revised rules for quality control of pharma products

Subject: Science and Tech

Section: Health

Context:

Recently, the Health Ministry notified revised Pharma manufacturing rules under schedule M to ensure quality control.

More on news:

The Central government, after consultation with the Drugs Technical Advisory Board, notified the revised rules under the Drugs (Amendment) Rules, 2023.
The revised Schedule M prescribes the Good Manufacturing Practices (GMP) and requirements of premises, plant, and equipment for pharmaceutical products as per global standards.
The Ministry had set a six-month deadline for small manufacturers and 12 months for large units to get their World Health Organization-Good Manufacturing Practices (WHO-GMP) certification.

Schedule M of the Drugs and Cosmetics Act, 1940:

It includes requirements of facilities and their maintenance, personnel, manufacture, control, safety testing, storage and transport of material, written procedures and records, and traceability for pharmaceutical products.

Revised Schedule M of the Drugs and Cosmetics Act, 1940:

The changes introduced in the revised Schedule M include introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and a computerized storage system for all drug products.
Manufacturers must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the license, and do not place patients at risk due to inadequate safety, quality, or efficacy.
Companies must market a finished product only after getting “satisfactory results” on tests of the ingredients.
Companies must retain a sufficient quantity of the samples of intermediate and final products to allow repeated testing or verification of a batch.
The focus will be on risk management, qualification and validation of equipment, and self-inspection will be vital contributions.
The revised Schedule M has 13 parts which provide GMP guidelines for the specific requirements for manufacturing pharmaceutical drugs.
The revised rules has five new categories of drugs including pharmaceutical products containing hazardous substances such as sex hormones, steroids (anabolic and androgenic), cytotoxic substances, biological products and radiopharmaceuticals.

About Good Manufacturing Practices (GMP):

GMP is mandatory standards which build and bring quality into a product by way of control on materials, methods, machines, processes, personnel, and facility/environment, etc.
GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945 in the year 1988
Amendment to this act was done in June, 2005 to replace the word, ‘Good Manufacturing Practices’ (GMP) with ‘Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products’.

Implementation Plans:

The revised rules are to be implemented on the basis of company turnovers
Medium and small manufacturers (with an annual turnover of less than ₹250 crore) who will have to implement the revised rules within 12 months from its date of publication.
Large manufacturers with an annual turnover of over ₹250 crore will be given six months to do so.

Benefit of revised guidelines.

The revised regulations of Schedule M will help ensure compliance with international quality standards.
It will benefit both patients and the industry by promoting the manufacturing of safe, effective, and high-quality drugs.

About Drugs Technical Advisory Board:

It is the highest statutory decision making body on technical matters pertaining to drugs in the country.
The body was formed under Drugs and Cosmetics Rules, 1940.
It is part of the Central Drugs Standard Control Organization which comes under the Ministry of Health and Family Welfare.
Its function is to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act