Centre to rope in states to enforce drug quality norms

New Delhi: The Drug Controller General of India (DCGI), is set to instruct states and Union territories to identify and take action against drugmakers failing to adhere to Good Manufacturing Practices (GMP), according to two official familiar with the matter. 

GMP is meant to ensures consistent production and quality control, vital for patient safety, product effectiveness, and preventing fake drugs. 

A recent revision of Schedule M GMP rules seeks to align India’s quality standards with global benchmarks in a bid to boost the country’s reputation as a reliable drug producer.

All large companies, with revenues exceeding ₹250 crore, are implementing GMP while smaller firms received an extension until 31 December to make the necessary upgrades.

“Those who have applied to implement GMP and upgrade their facility have got time till December. Now state governments have to verify the compliance of those companies who have not applied. Now, DCGI may issue some direction to the State/UTs to look into this matter and identify non-compliance firms,” said the official.

“The matter was also discussed sometime back involving officials from Niti Aayog, pharma associations and Central Drugs Standard Control Organization (CDSCO),” the second official said.

About 8,500 of India's 10,000 pharma companies are small businesses, concentrated in Maharashtra, Gujarat, Himachal Pradesh, and Andhra Pradesh. Only 2,000 of these MSMEs currently have GMP certification from the World Health Organization. 

According to government estimates, the Indian pharmaceutical market was valued at an estimated $50 billion in FY 2023-24, with domestic consumption accounting for $23.5 billion.

Globally, India's pharmaceutical industry stands as the third largest by volume and the 14th largest by value, being the foremost supplier of generic drugs worldwide, contributing approximately 20% of the global supply. 

This encompasses the production of around 60,000 generic brands across 60 therapeutic categories. Key segments within this robust industry include generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research & manufacturing, biosimilars, and biologics.

In 2023, the government revised Schedule M of the Drugs and Cosmetics Rules, 1945, making new GMP standards mandatory for drug manufacturers. This initially applied to companies with an annual revenue of ₹250 crore and above, and has now been extended to MSME drug firms.

This was prompted by incidents of contaminated Indian cough syrups leading to child deaths in the Gambia and Uzbekistan two years ago. 

Harish Jain, President of the Federation of Pharmaceutical Entrepreneurs (FOPE), stated that Micro, Small, and Medium Enterprise (MSME) drug firms that requested an extension from the drug regulator to implement Good Manufacturing Practice (GMP) compliance are actively upgrading their facilities within the agreed timeframe. He added that any firms not seeking an extension are presumed to be already adhering to the GMP protocols.

Dr R.V. Asokan, former president of the Indian Medical Association (IMA) said that as the Indian pharma industry began growing exponentially in the last 25 years, the power to approve drugs was delegated from the Central Drug Authority (CDA) to the state drug authorities. 

Small states like Uttarakhand and Himachal Pradesh benefitted from business-friendly regulations and GMP was not enforced strictly. 

"Because of lack of infrastructure and human resources quality assurance is less than satisfactory. The deficiencies, due to the lack of GMP regulations may differ from one company to another. These gaps could be around storage, manufacturing, waste management, ventilation and infrastructure at the pharma units,” he added.

Queries sent to the health ministry remained unanswered till press time.