Ministry issues revised rules to ensure quality in pharma sector

The rules ‘would bring our GMP recommendations on a par with global standards, especially those of the WHO, and ensure production of high quality, globally acceptable drugs’, a Health Ministry official said

Updated - January 12, 2024 09:37 am IST

Published - January 12, 2024 08:47 am IST

The contamination of cough syrup has caused a huge uproar and left the pharma sector under a cloud.

The contamination of cough syrup has caused a huge uproar and left the pharma sector under a cloud. | Photo Credit: Getty Images

The Ministry of Health and Family Welfare late last week notified revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945. The revision aims to ensure that the pharma sector recommits to the manufacture of safe, effective, and high-quality drugs in compliance with international quality standards, thus benefiting both patients and industry. This is a response to the backlash India has been receiving over reports of sub-standard medicine being exported from India.

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Last year, the country felt intense global scrutiny after the World Health Organization (WHO) issued an alert about cough syrups being contaminated with diethylene glycol and ethylene glycol. These are considered toxic to humans and can prove fatal. The contamination was allegedly found in samples taken from a batch of cough syrup made by QP Pharmachem Ltd, based in Punjab. QP Pharmachem Ltd’s manufacturing licence was suspended after cough syrup, linked to child deaths in Gambia and Uzbekistan, were found to be contaminated. Other cases of alleged contamination have also been reported from cough syrups made in India.

The latest revision includes five new categories of drugs — pharmaceutical products containing hazardous substances such as sex hormones, steroids (anabolic and androgenic), cytotoxic substances, biological products and radiopharmaceuticals. It also has additional sections including — the introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and a computerised storage system for all drug products.

According to the new notification, the manufacturer must assume responsibility for the quality of pharmaceutical products to ensure that they are fit for use, comply with the requirements of the license, and do not place patients at risk due to inadequate safety, quality or efficacy.

Additionally, companies must market a finished product only after getting “satisfactory results” from tests of the ingredients and retain enough of the samples of intermediate and final products to allow repeated testing or verification of a batch.

Explaining the rationale, a senior Health Ministry official said the pharmaceutical manufacturing and quality domain has evolved significantly in last 15-20 years.

“Our understanding of the domain has increased because of development in pharmaceutical and manufacturing sciences. The linkage between manufacturing and product quality and interdependence has been established. Also, observations from ongoing risk-based inspections further emphasise the need for a relook at current Good Manufacturing Practices (GMP) regulations and quality management systems being followed by pharmaceutical manufacturers.” Based on the above factors and to keep pace with fast-changing manufacturing and quality domain, there was a need to revisit and revise the principles and concept of GMP mentioned in current Schedule M. “This would bring our GMP recommendations on a par with global standards, especially those of the WHO, and ensure production of high quality, globally acceptable drugs,” he added.

Good Manufacturing Practices (GMP) are mandatory standards which enhance quality 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, and the last amendment was done in June, 2005.

In August, 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. The revised rules are set to be implemented on the basis of company turnovers. Medium and small manufacturers include those with an annual turnover of less than Rs 250 crore. These who will have to implement the revised rules within 12 months from the date of publication, whereas large manufacturers with an annual turnover of over Rs 250 crore will be given six months.

The revised Schedule M has 13 parts which provide GMP guidelines on specific requirements for manufacture of pharmaceutical drugs.

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