The updated Schedule M was announced on December 28, 2023, and is said to be more stringent than the World Health Organization (WHO) Good Manufacturing Practice (GMP) in some aspects.
According to a letter sent by Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi, seen by News18, licensed premises must be inspected by central and state inspectors at least once every three years and more frequently if required.
As Plan M, which aims to improve the quality of medicines made in India, comes into force, the drug regulator has now directed officials across the country to start auditing drug manufacturing units to ensure they comply with the new standards.
While the government plans to conduct surprise inspections of these units for up to four days on a company, the companies will be selected for risk-based inspections.
India has about 10,000 pharmaceutical manufacturing units, of which more than 80% are micro, small and medium enterprises (MSMEs).
Apart from this, the drug regulator Central Drugs Standard Control Organization (CDSCO) has made it mandatory to comply with Schedule M regulations for issuing new manufacturing licenses and retention letters.
Also Read | 'Plan M' to be implemented to improve quality of medicines made in India, manufacturers will have one year deadline to complete
The updated Schedule M, which is said to be stricter in some aspects than the World Health Organization's (WHO) Good Manufacturing Practices (GMP), was announced on December 28, 2023. The rule covers pollution complaints from The Gambia, Uzbekistan, the United States, the Marshall Islands and Micronesia. The WHO drug alert even highlighted some of these allegations, raising questions about the quality of Indian medicines.
The government has decided that companies with a turnover below Rs 250 crore will have one year to make the transition, while companies with a turnover above Rs 250 crore will be required to implement “Schedule M” within the next six months.
Inspections should be carried out at least every 3 years: DCGI
A letter from drug regulator Rajeev Singh Raghuvanshi seen by News18 shows that licensed premises must be inspected by central and state government inspectors. They are required to inspect premises for compliance with licensing conditions and rules at least every three years, or more frequently depending on the risk.
“…it is also required that licensed premises shall be inspected jointly by inspectors appointed by the Central Government and the State Government to verify compliance with the conditions of the license and the provisions of the Act and these Rules not less than once every three years or on a risk-based approach needs.
The letter also stipulates that regulations must be followed when granting new licenses. “It is also required that, if applying for a fresh production license, the license will be issued to the applicant only after determining compliance with the regulations. Schedule M…” the letter dated August 2 reads.
It also said state compliance verification would be required during the issuance of a hold letter. “It is worth mentioning here that various categories of production licenses are issued under the Drugs and Cosmetics Act and these licenses remain valid if the licensee pays the license retention fee every five years from the date of issuance, Unless the license is suspended or canceled by the licensing agency.
“…all state and UT drug control officers are required to ensure compliance with…Schedule 'M'…during consideration of applications for license retention…”
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