Centre imposes stringent quality controls on pharma companies

Aksheev Thakur

New Delhi, January 6

The Centre has tightened rules to ensure strict compliance with good manufacturing standards, which look at bringing quality control on manufacturing plants, machines, safety and personnel by pharmaceutical companies.

With the revised Schedule M notified by the Union Health Ministry, the concept of pharmaceutical quality system, quality risk management, product quality review, validation of equipment, change control, self-inspection, quality audit team and supplier audit and approval have been introduced.

What new norms stipulate

• Revised norms come in wake of deaths due to India-made cough syrups overseas in 2022
• Pharma companies can only market finished products after obtaining satisfactory results from tests
• In case of quality failures or serious adverse events, the products must be recalled
• Units must list basic hygiene requirements for personnel handling products

Schedule M prescribes pharmaceutical companies to inform the licensing authority about product defects and their maintenance, deterioration or faulty production, manufacture process, storage and written documentation of the products.

The revised guidelines come in the wake of deaths due to India-made cough syrups overseas in 2022.

The manufacturers must ensure that their products are suitable for their intended use and comply with licensing requirements, and do not put patients at risk due to insufficient safety, quality or effectiveness.

Moreover, companies can only market finished products after obtaining satisfactory results from tests. The government stated that in case of quality failures or serious adverse events or life-threatening situations, the products must be recalled in a prompt and effective manner up to the retailers’ level. The recalled products should be secured in a segregated area.

All pharma companies must lay down procedures listing the basic hygiene requirements for personnel entrusted with the handling of products. The personnel should not work if they have infectious diseases or skin diseases.

In a notification issued by the Health Ministry, MSME units with an annual turnover of Rs 250 crore will have to adopt good manufacturing practices within 12 months. The companies with an annual turnover of over Rs 250 crore have to ensure these compliances in the next six months. Of the 10,500 drug firms, 8,500 are MSMEs.

In August 2023, the Health Ministry had stated that in inspections of 162 drug factories and 14 public testing labs since December 2022, the major issues which were found included faulty design of testing areas, absence of documentation and lack of professionally trained employees. It had added that of the 8,500 small drug companies, only 2,000 were found to be in compliance with the standards set by the World Health Organisation.