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

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, Union Health Minister Mansukh Mandaviya said on Wednesday.

“Those who do not comply with the direction will face suspension of licence and/ or penalty,” he said.

Listen to this article

00:00

1x 1.5x 1.8x

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.

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, Union Health Minister Mansukh Mandaviya said on Wednesday.

“Those who do not comply with the direction will face suspension of licence and/ or penalty,” he said.

Story continues below this ad

The decision is important as only 2,000 of the 10,500 manufacturing units in the country were found to be compliant with the global WHO-GMP standards, he said.

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, said officials.

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 management, product quality review, and validation of equipment.

Explained

Quality control

ONLY 2,000 of the 10,500 manufacturing units in the country have been found to be compliant with the global WHO-GMP standards. Now, all will have to implement the revised GMP, ensuring quality medicines for the domestic market and abroad.

Experts said that while some of these processes were followed, they weren’t documented properly, as required by global regulators. The companies will also have to introduce a GMP-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,” said an expert.

Story continues below this ad

Express Opinion | How India’s drug regulatory regime can ensure greater credibility for our pharma industry

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,” said the expert.

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. Among other things, this lists the specifications of the manufacturing units, processes that need to be followed, and equipment needed.

“This is a very welcome step as it will ensure that all the manufacturing units are at par with global standards, reducing the need for repeated inspections by different regulators. It will also make India a quality pharmaceutical hub, and ensure that our citizens receive export-quality medicines too,” said Narender Ahooja, former drug controller of Haryana.

Anonna Dutt

Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government’s management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country’s space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University’s Dart Centre. Dutt has a Bachelor’s Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More

Stay updated with the latest - Click here to follow us on Instagram

Loading Taboola...

Public Safety Minister Gary Anandasangaree said the designation gives law enforcement “enhanced powers to combat a group that has instilled fear through violence and intimidation”.

Canada designates Lawrence Bishnoi gang a terrorist entity

Cities8 hr ago

The Canadian government has labeled the Lawrence Bishnoi gang as a terrorist group, granting authorities more authority to combat their violent behavior. The gang, operating in British Columbia, Ontario, and Alberta, has been connected to 50+ violent incidents since 2023.

View all shorts

Live Blog