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Parliamentary panel calls for standard licensing process for Ayush drugs to meet global scientific scrutiny

Gireesh Babu, New Delhi
Wednesday, December 15, 2021, 08:00 Hrs  [IST]

A Department-Related Parliamentary Standing Committee on Health and Family Welfare has recommended to the Ministry of Ayush to establish a standard licensing process based on uniform parameters across all the States so that the drug formulations do not vary in different States and also conform to global norms of safety and efficacy. This would go a long way in establishing the Indian System of Medicine as an alternative system of medicine, it said.

The Committee, looking into the action taken by the Ministry of Ayush on its earlier recommendations on the Demands for Grants 2021-22, expressed its disappointment that the Ministry has not given any information about reasons for poor export of ASU&H drugs.

“The Committee's concerns about ASU drugs failing to meet global norms on safety and efficacy have not been addressed. The Committee is also surprised that the Ministry has not paid attention to the point highlighted by it regarding lack of uniformity in the approach of different States with respect to ASU Drugs as Health is a State subject. The Committee emphasises that given the increasing popularity of Ayush systems especially during pandemic Covid-19, it is high time to showcase the effectiveness of ASU&H drugs in domestic market as well as global arena,” said the Committee headed by Member of Parliament Prof. Ram Gopal Yadav in a latest report in December.

The Ministry should reconsider its earlier recommendation relating to creation of a specialized body for Ayush Drug Control with requisite expertise at the State level on lines of the vertical structure for Ayush under CDSCO and also explore the feasibility of setting up of a specialized body especially for Ayush Drugs Control at the State Level.

The role of the Pharmacopoeia Commission of Indian Medicine for maintaining standards of Ayurveda, Siddha, Unani & Homoeopathy drugs need to be strictly monitored for assured standardization of ASU&H drugs. It has also recommended that States/UTs must be motivated and incentivized to ensure standardization of Ayush education and quality healthcare delivery system in general and on quality control of ASU&H drugs in particular.

It also opined that merely by writing to States Governments to check the practice of Ayush System by quacks, the Ministry of Ayush should not absolve itself of its responsibility to stop this menace as it not only brings disrepute to the Ayush system of medicine but also discourages people to have trust in this system.


“The Ministry, therefore, must think of devising a certain code under which stern legal action could be taken against the quacks. The Committee also recommends that the ministry of health & family welfare must examine and consider the regulatory amendments under Drugs and Cosmetics Act, 1947 as suggested by the Ministry of Ayush without delay to improve the quality, efficacy and safety of ASU drugs. The Ministry of Ayush must take up this matter with the ministry of health & family welfare on priority basis and inform the Committee on the action taken on the matter,” it said.

The Ministry must devise a concrete strategy to address the issue of practice of Ayush system of medicine by quacks which has eroded the faith of the public in the system.

It also recommended the Ministry to study and take advantage of the Chinese experience of integrating traditional Chinese Medicine with the modern system of medicine. The Committee would like the Ministry to prepare a comprehensive and specific course of action to re-discover the glorious past of the Ayush system that reigned and ruled the world healthcare delivery system.

The Committee observed that the recruitment process for filling up of nine regulatory posts for creation of a vertical structure progressing at a snail's pace and strongly recommended that the creation of vertical structure for Ayush under CDSCO should be expedited and the recruitment process be completed at the earliest.

The Committee taking into account that although it is mandatory for all ayurvedic medicine manufacturers to comply with the standards prescribed under ayurvedic Pharmacopoeia of India (API) which includes Pharmacopoeial standards for heavy metals content, microbiological limits, aflatoxins, etc., said that however, it is skeptical about the adherence to these prescribed standards in the absence of proper monitoring and supervision.

The Committee, time and again, has been emphasising upon quality control of ASU&H drugs with the purpose of popularising its domestic use and global acceptance. It has expressed its hopes that all components of the new scheme outlined for the duration of 15th Finance Commission would be implemented effectively to strengthen the whole regime of standardisation, scientific validation, Pharmacovigilance, etc.

The Committee reiterated its recommendation regarding increasing the credibility of Ayush system to meet scientific global scrutiny and scientific validation of new Ayush drugs development including pre-clinical and clinical trials to showcase its evidence based products.

 

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