New Delhi: Ayurvedic, Siddha, Unani and Homoeopathic drugs are regulated in accordance with the exclusive provisions for them in the Drugs & Cosmetics Act, 1940, and rules under it. These drugs have to adhere to such standards and quality control parameters as given in the authoritative books, pharmacopoeias and formularies of Ayurvedic, Siddha, Unani and Homoeopathic systems, which are different from that prescribed for allopathic medicines — Minister of State (Independent Charge) for AYUSH Shripad Yasso Naik in his written reply to a question in Lok Sabha today.

Till date, monographs of quality standards of 645 single drugs & 202 compound formulations of Ayurveda, 298 single drugs & 150 compound formulations of the Unani system, 139 single drugs of Siddha and 1,117 monographs of Homoeopathic drugs have been published in the respective pharmacopoeias. Similarly, Ayurvedic Formulary contains 985 standardised formulations, Unani Formulary 1,229 formulations and Siddha Formulary has 399 standardised formulations.

Under the provisions of Drugs & Cosmetics Rules, 1945, good manufacturing practices and quality standards prescribed in the respective pharmacopoeias are mandatory for the manufacturing of licensed Ayurvedic, Siddha, Unani and Homoeopathic medicines. In addition, two voluntary certification schemes for these medicines are implemented respectively by the Quality Council of India for grant of AYUSH Standard & AYUSH Premium marks and quality certification of products as per WHO-GMP and COPP guidelines by the Central Drugs Standard Control Organisation (CDSCO).

The Appellate Laboratories for Indian Medicine and Homoeopathy under the provisions of Drugs & Cosmetics Rules, 1945 have reported testing of referred samples of Ayurvedic, Siddha, Unani and Homoeopathy drugs during last 3 years as under.

Year Pharmacopoeial Laboratory of Indian Medicine Homoeopathic Pharmacopoeial Laboratory
  Samples tested Samples failed Samples tested Samples failed
2014-15 11 4 401 142
2015-16 25 1 351 150
2016-17 37 1 387 49

The appellate laboratories after testing of the referred samples send the analysis reports to the concerned authority for necessary action. State licensing authorities and drug controllers regulate and control the quality of Ayurvedic, Siddha, Unani and Homoeopathic medicines.

As per the information made available from the States, 11,889 samples of AYUSH medicines have been tested in 24 States during the period 2013-14 to 2015-16 out of which 254 samples failed in quality testing. The State licensing authorities reported having initiated appropriate actions against the samples not complying with the standards including the issuance of show cause notice, suspension or cancellation of license, recall of the concerned batch of medicines from the market and prosecution.