Drug Makers To Face Stricter Audits, Surprise Inspections As ‘Schedule M’ Quality Rules Come Into Effect

With ‘Schedule M’ coming into effect to improve the quality of India-made medicines, the drug regulator has now instructed officers across the country to begin audits of drug-making units to ensure they are meeting the new standards.

While the government is planning surprise inspections at these units taking up to four days at a single firm, the companies will be chosen for risk-based inspections.

India has around 10,000 pharmaceutical manufacturing units, of which over 80 per cent are micro, small and medium enterprises (MSMEs).

Alongside this, the drug regulatory agency Central Drugs Standard Control Organisation (CDSCO) has made Schedule M compliance mandatory for issuing new manufacturing licenses and retention letters.

The updated Schedule M, which is claimed to be stricter than the World Health Organization’s (WHO) good manufacturing practices (GMP) in some aspects, was announced on December 28, 2023. India decided to adopt this rule after facing several allegations by global regulators, including contamination complaints by Gambia, Uzbekistan, the US, the Marshall Islands and Micronesia. Some of these allegations were even highlighted by WHO’s drug alert raising questions over the quality of Indian drugs.

The government had decided that firms below a turnover of Rs 250 crore will be given a year to make the transition, whereas companies above a turnover of Rs 250 crore will be asked to execute ‘Schedule M’ in the next six months.

CHECKS SHOULD BE MADE AT LEAST ONCE EVERY 3 YEARS: DCGI

According to the letter sent by drug regulator Rajeev Singh Raghuvanshi, seen by News18, the licensed premises must be inspected by both a central government and a state government inspector. They need to check that the premises meet the license conditions and rules at least once every three years or more often if needed based on risk.

“…it is also required that the licensed premises shall be inspected jointly by the inspector appointed by the Central Government and State Government to verify the compliance with the conditions of licence and the provisions of the Act and these rules not less than once in three years or as needed as per risk based approach.”

The letter also makes compliance mandatory for the grant of fresh licences. “It is also requested that in case of an application for a fresh manufacturing licence, the licence shall be issued to an applicant only after ascertaining the compliance with. Schedule M…,” said the letter dated August 2.

It also says that the verification of compliance by the state needs to be carried out during the issue of the retention letter. “It is pertinent to mention here that various categories of manufacturing licences are issued under the Drugs and Cosmetics Act and these licences remain valid if the licensee deposits a licence retention fee every succeeding five years from the date of its issue, unless, it is suspended or cancelled by the licensing authority.”

“…during the consideration of the licence retention application, all the state and UT drugs controllers are requested to ensure the compliance …under Schedule ‘M’…”

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