Mandatory clinical trials for homeopathy drugs soon

New Delhi: India, which has now jumped to the second spot after China as the leading exporter of herbal products, will soon make it mandatory for all new traditional medicines to undergo clinical trials before hitting the market.

This will include only the new patented drugs and not the classical formulations that find mention in India’s ancient texts, some of which are 5,000 years old.

Till now, there has been no formal protocol on how traditional drugs should be tested for safety.

Besides, the Drug Controller General of India (DCGI) has no expertise to handle herbal medicines.

The department of AYUSH (Ayurveda, Unani, Siddha and Homeopathy) is now pushing a proposal to have two separate drug controller generals – one for allopathic medicine and another for traditional medicine.

The Expenditure Finance Committee has also approved creation of Central Drug Controller for AYUSH drugs. There are around 10,000 ASU (Ayurveda, Siddha and Unani) drugs’ manufacturing units in the country.

Union health minister Ghulam Nabi Azad recently said, “To ensure the quality and standards of ASU medicines and effective enforcement of the provisions of the Drugs & Cosmetic Act, the Ayurveda, Siddha and Unani Drugs Consultative Committee (ASUDCC) recommended creation of separate drug controllers for ASU drugs. It will facilitate the increased acceptability of Ayurveda, Unani, Siddha and Homoeopathy medicines within the country and abroad.”

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