drug regulation

Reality check: Forget clinical tests, there is no proper definition of what a new AYUSH drug is

A parliamentary committee finds drugs claiming to treat cancer, obesity, hypertension and other conditions without any clinical trials.

The ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy or AYUSH has ambitious plans of curing cancer and AIDS with the traditional systems of Indian medicine. But before that it has to fix the yawning gaps in the licensing of drugs that come under its purview, of which many are in the market without any clinical trials.

This was revealed in the Rajya Sabha Committee report, tabled last fortnight.

The secretary of the Ministry of AYUSH, Ajit Sharan deposed before the committee in March and said that many states do not even have AYUSH inspectors. States are licensing authorities and the secretary admitted that they are “very ill equipped, both technically and infrastructurally, to handle this task.”

Many states rely on the drug inspectors from the allopathic side, for whom testing AYUSH drugs would be low priority.

In the last three years, only 11,889 samples of AYUSH medicines were tested in 24 states during the last three years from 2013 to 2015, Union AYUSH minister, Sripad Naik said in Rajya Sabha. In comparison, last year, drug inspectors collected about 40,000 samples of allopathic drugs from all over the country.

No proper definition

The more revealing concern is that there is no proper definition of what a new AYUSH drug is. A new drug under the Drugs and Cosmetics Act, 2008 is a drug which is usually a new molecule or fixed dose combination – or a known drug that is now proposed to be marketed with modified or new claims. A new drug undergoes a clinical trial, before it is licensed and manufactured. However, for AYUSH drugs, there is no clear guideline under the law, the committee said.

“There are no stringent norms requiring the manufacturer to provide rigorous proof of both safety and efficacy of the new AYUSH drug and the license is given without proof of efficacy and safety,” the committee noted. Besides, the State Licensing Authorities do not know how to give licence to a new drug with new indications, Sharan told the committee.

While the Act at least mentioned Ayurveda, Unani and Siddha medicines, it does not even mention Homeopathy medicines. Which means that there is no law that regulates homeopathic medicines.

“We are alive to the situation and are working on the problem,” said Jitendra Sharma, joint secretary, AYUSH. "We are working on the definition of a new drug and suggest other related amendments to the Drugs and Cosmetics Act. The committee will include experts from Central Drug Standard Control Organisation, an AYUSH expert, among others."

Sharma said that while some classical drugs have been “time tested” for over 5,000 years, the other new drugs are suspect. The committee noted that in the past 20 to 30 years, there have been drugs claiming to treat cancer, obesity, hypertension and other conditions that have been introduced as patent or proprietary drugs that make exaggerated claims.

“In the garb of Ayurveda or Unani, absurd combinations should not... [be manufactured and distributed in the market] without being put through the rigours of science,” said Sharma. The ministry has also created new posts for drug inspectors in the country.

The Committee, therefore, recommended the need for:

“a credible regulatory and certification system that manufacturers of all patent and proprietary ASU&H drugs which have been introduced in the market in the last ten years, should be required to prove their efficacy and safety through clinical trials over the next five years. “

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