"Drugs and Cosmetics Rules amended to reform Ayurvedic medicine manufacturing standards"
Good Manufacturing Practices (GMP)
WHO-prescribed standards for pharmaceutical manufacturing covering premises, personnel, and quality control
Schedule M-1
Appendix to Drugs and Cosmetics Rules specifying GMP norms specifically for Ayurvedic, Siddha, and Unani drug manufacturers
Ayurvedic medicine in India is regulated primarily under the Drugs and Cosmetics Act, 1940, which applies to AYUSH formulations alongside allopathic drugs. The institutional architecture for AYUSH was significantly upgraded when the Department of AYUSH was elevated to a full Ministry of AYUSH in 2014, signalling a policy shift toward mainstreaming traditional medicine. The National Commission for Indian System of Medicine Act, 2020 modernised the regulatory framework for education and practice, replacing the older Indian Medicine Central Council Act, 1970. Constitutionally, health is a State List subject under Entry 6 of the Seventh Schedule, but the Union government exercises significant influence through centrally sponsored schemes such as the National AYUSH Mission (NAM) and through central drug regulation under the Drugs and Cosmetics Act.
The Drugs and Cosmetics Rules, 1945 — framed under the 1940 Act — govern the licensing, manufacturing standards, and quality control of all drugs including Ayurvedic, Siddha, and Unani (ASU) formulations. Schedule M-1 of these Rules specifically prescribes Good Manufacturing Practices (GMP) for ASU drug manufacturers. Historically, the regulatory framework for Ayurvedic manufacturing has been criticised for being less stringent than that for allopathic drugs, creating quality assurance gaps that have hampered both domestic consumer confidence and export prospects. The recent amendments to the Drugs and Cosmetics Rules represent the most substantive revision of this framework in recent years.
The amended Rules 154 and 154A convert manufacturing licences from periodically renewable (every five years) to permanently valid. This aligns Indian practice with global lifetime-licence norms seen in several advanced regulatory jurisdictions and is intended to reduce administrative burden and eliminate delays caused by renewal backlogs. Simultaneously, Rules 156 and 156A — which governed the renewal process and its conditions — have been repealed, streamlining the licensing architecture.
On the quality-control side, the amended Rule 160B(2)(ii) mandates the appointment of microbiologists with both undergraduate and postgraduate qualifications and quality-control experience. This professionalises the quality-assurance function within manufacturing units and aligns with the World Health Organization's Good Manufacturing Practices (GMP) norms, which India has committed to meeting as part of its ambition to become a global hub for herbal medicine exports. …
With reference to Ayushman Bharat Digital Mission, consider the following statements:
1.Private and public hospitals must adopt it.
2.As it aims to achieve universal health coverage, every citizen of India should be part of it ultimately.
3.It has seamless portability across the country.
Which of the statements given above is/are correct?
With reference to the recent amendments to the Drugs and Cosmetics Rules, 1945 for Ayurvedic medicine manufacturers, consider the following statements:
1.Manufacturing licences issued under the amended Rules are now permanently valid instead of requiring renewal every five years.
2.Shelf-life of Ayurvedic products can now be determined through accelerated stability studies without any requirement for subsequent real-time validation.
3.AYUSH autonomous laboratories have been empowered to act as central drug laboratories under the amended Rules.
Which of the statements given above is/are correct?
Which of the following best describes 'Schedule M-1' in the context of Indian pharmaceutical regulation?
With reference to the constitutional and regulatory framework for AYUSH in India, which of the following statements is/are correct?
1.Health is a State List subject under the Seventh Schedule of the Constitution.
2.The Drugs and Cosmetics Act, 1940 applies to Ayurvedic formulations in addition to allopathic drugs.
3.The National AYUSH Mission is a centrally sponsored scheme that funds infrastructure and quality control at the state level.
Want the full note, Prelims Facts & MCQ answers?
Create a free account — takes less than a minute.
Create free account