India plans to amend drug rules to appoint subject-expert inspectors for homoeopathic medicine manufacturing units. The Drugs Consultative Committee met on 18 September to discuss this change. "Inspection of the manufacturing units requires subject expertise," the minutes showed. This move aims to ensure better safety and quality for the industry.
Summary
Inspectors of homoeopathic medicines must hold the appropriate qualifications, an industry body said, adding that domain expertise enables better guidance for manufacturers and pharmacists.
New Delhi: India plans to amend its drug regulation rules to recognize homoeopathic degrees as the requisite qualification for inspectors overseeing plants that manufacture these alternative medicines, aiming to ensure safety and quality through domain expertise, according to two government officials and two documents reviewed by Mint.
The Central Drugs Standard Control Organisation will amend Rule 49 of the Drugs and Cosmetics Rules, 1945, to recognize a degree in homoeopathy or specialization in homoeopathic pharmacy for appointments under Section 21 of the Drugs and Cosmetics Act, 1940.
The current rules do not recognize homoeopathic degrees as an educational qualification for the appointment of inspectors who will be responsible for India's Ayush (ayurveda, yoga and naturopathy, unani, siddha and homoeopathy) services economy of $36.92 billion, with exports totalling $1.25 billion.
The proposal was taken up by the Drugs Consultative Committee (DCC), the advisory panel on drug regulation, at a meeting on 18 September chaired by Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI).
"DCC agreed in principle that suitable provisions should be included in the rules for recognized qualifications and experience in Homoeopathy only for manufacturing at present, as inspection of the manufacturing units requires subject expertise," the minutes of the meeting showed.
According to the meeting minutes seen by Mint, the DCC deliberated on the absence of a specific qualification in Rule 49 for inspection of homoeopathic drugs. It was observed that inspection of a manufacturing facility involves assessment of the system of medicine as well as common manufacturing, quality-control and good manufacturing practice requirements.
The initiative originated after the ministry of Ayush held discussions at the Ayurvedic, Siddha and Unani Drugs Consultative Committee meeting on 12 June and wrote to the DCGI to consider the proposal.
Homoeopathic qualifications
Homoeopathic medicines are currently regulated under provisions of the Drugs and Cosmetics Act, which empowers drug inspectors to oversee the manufacturing units. However, the rules do not recognize qualification in homoeopathy, according to a second government document.
"It is proposed that recognized qualification in Homoeopathy, which includes a degree in Homoeopathy and/or a qualification or specialization in Homoeopathic Pharmacy, be included among the qualifications prescribed under Rule 49 of Drug Rules, 1945, for appointment as inspector," it stated.
Inspectors of homoeopathic medicines must hold the appropriate qualifications, an industry body said, adding that domain expertise enables better guidance for manufacturers and pharmacists, especially regarding over-the-counter formulations.
"Having technically qualified inspectors ensures that drugs produced by pharmaceutical companies are safe, ultimately protecting patients undergoing treatment across the country," said Dr. A.K. Gupta, Secretary General, The Homoeopathic Medical Association of India.
Queries emailed to the DCGI office, the health ministry spokesperson and the ministry of Ayush on Tuesday afternoon remained unanswered at publishing time.