Adopt WHO-standard good manufacturing practices: Govt sets deadline for pharmas

Subject :Science and technology

Section: Health

Context:

Following recent incidents of several countries reporting deaths allegedly linked to “contaminated” India-manufactured drugs, the government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) which were revised in 2018, bringing them on par with World Health Organisation (WHO) standards.

Details:

Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months, while medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year.
Those who do not comply with the direction will face suspension of license and or penalty.
The move comes after a risk-based inspection of 162 such units and 14 testing labs found several deficiencies, including:
- absence of testing of raw materials before use,
- absence of quality failure investigation of its products,
- faulty design of manufacturing and testing areas.
According to officials, this will lead to at least 11 specific changes in the manufacturing process on the ground, including:
- introduction of a pharmaceutical quality system,
- quality risk man-agement,
- product quality review, and
- validation of equipment.
- Introduction of aGMP-related computerised system.
  - These computer programmes will be designed to automatically record all the steps followed and checks done, which will ensure all the processes are followed.

The companies will also have to carry out stability studies as per the climate conditions.
- At present, most companies store their samples under recommended conditions and test for various parameters from time to time.
- Now, they will have to keep the drugs in a stability chamber, set the proper temperature and humidity, and carry out an accelerated stability test as well.
Currently, while companies exporting medicines to other countries already have to be WHO-GMP certified, those manufacturing medicines for the domestic market can be granted permission if they meet the requirements listed in Schedule M of rules under the Drugs and Cosmetics Act.
- Schedule M is a section of the Drugs and Cosmetics Act of 1940 that outlines the ‘Good Manufacturing Practices’ (GMP) for pharmaceuticals in India. These are the standards that pharmaceutical manufacturers must adhere to to ensure the quality, safety and efficacy of their products.

About the WHO-GMP:

Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.

GMP guidance:

The first WHO draft text on GMP was adopted in 1968.
In 1969, when the World Health Assembly recommended the first version of the WHO Certification Scheme on the quality of pharmaceutical products moving in the global market, it accepted the WHO GMP as an integral part of the Scheme.
A supplementary annex on biological medicinal products was adopted by the Expert Committee on Biological Standardization (ECBS) in 1991 and establishes the general approach to the quality control of biological medicines that include products such as vaccines, blood and blood products, antigens, cell and tissue therapies, biopharmaceutical products, and others.
More than 100 countries have incorporated the WHO GMP provisions into their national medicines laws, and many more countries have adopted its provisions and approach in defining their own national GMP requirements. The WHO GMP continues to be used as a basis for the WHO Certification Scheme and prequalification of vaccines for procurement by UN agencies.