SCHEDULE-M

SCHEDULE-M

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July 17, 2023

Mansukh Mandaviya, the central minister of Chemicals and Fertilizers, recently announced that the Indian government will launch Schedule M Compliance for all MSME pharma companies. This scheme pertains to maintaining the safety and quality of all products manufactured by MSME firms. Additionally, it will also help in improving product efficacy and will be mandatory for all MSME firms.

What is Schedule M?

               • In the Drugs and Cosmetics Act enacted in 1940, there is a section on Schedule M that mentioned 'Good Manufacturing Practices' in India for the pharmaceutical sector. Hence, all pharma firms should follow the standards mentioned in GMP to guarantee product safety, quality, and efficacy.

               • The Ministry of Family and Health Welfare recently carried out an operation to determine the quality of pharma goods throughout the country. Of them, 105 firms were found to violate GMP rules, and strict action was taken against them.

Schedule M Characteristics

               • It includes the various types of manufacturing aspects like raw materials, equipment, premises, personnel, quality control, distribution, recall documentation, and storage.

               • It also emphasizes the necessity of various drugs like biological products, topical preparations, oral liquids, sterile Products, oral solids, etc.

               • It regulates the guidelines for maintenance, cleaning, calibration, sanitation, and validation of the equipment and its facilities.

               • It focuses on maintaining hygiene, personal protective equipment, and training for the working staff of manufacturing plants.

               • It regulates the maintenance and preparation of different reports and records like reports on quality control, stability studies, standard operating procedures, batch records, and distribution records.

Details of SCHEDULE-M

               • To prevent consumers from hazardous drugs a directive has been issued to the regulatory authorities for carrying out factory audits and inspections. It can be helpful as such an operation will prevent consumers from buying counterfeit or substandard drugs from the market.

               • The minister declared that the policy will become mandatory in a phased manner for all the MSME pharma firms as it deals with requirements for manufacturing goods. Additionally, he added that it will improve the competitiveness and compliance of the firms and will add to the export value.

Challenges to SCHEDULE-M

               • Due to inadequate infrastructure, resources, and manpower, Schedule M cannot be implemented in the whole country.

               • Schedule M compliance

               This is time-consuming and costly so medium and small manufacturers may not have the financial prowess and technical expertise to comply with it.

Source - The ET & The HINDU