ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA,
YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY
(SHRI SHRIPAD YESSO NAIK)
(a): The States/UTs wise number of AYUSH hospitals/dispensaries is furnished at Annexure-I.
(b): Information received from some States/UTs regarding the number of ASU&H medicines tested and declared spurious/ sub-standard/adulterated during the last three years is placed at Annexure-II.
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(c) & (d): The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules,1945 have provisions for the regulation and quality control of Ayurvedic and Unani medicines in the country, which are enforced by the State Governments. It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units & medicines including proof of safety & effectiveness and comply to Good Manufacturing Practices (GMP) and quality standards of drugs given in the pharmacopoeia. Spurious, Adulterated and Misbranded medicines and the penal provisions thereto are defined in the Act. Accordingly, the Licensing Authorities/Drugs Controllers appointed by the State Governments are empowered to take necessary action against the defaulters acting in contravention of the legal provisions.
Following steps have been taken by the Government for effective quality control of AYUSH medicines:
1) Rule 158-B in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Ayurvedic and Unani medicines in accordance with the proof of safety and effectiveness.
2) Display of shelf-life for expiry date on the label of medicines has been made mandatory under the provisions of Drugs and Cosmetic Rules, 1945.
3) Scheduled list of potentially hazardous substances of Ayurvedic and Unani systems is notified under the provisions of Drugs and Cosmetics Rules, 1945. It is mandatory for the manufacturer to label the container with the words “Caution: To be taken under medical supervision” both in English and Hindi languages for the formulations containing such ingredients.
4) 27 State Drug Testing Laboratories and 47 State Pharmacies have been supported for strengthening their infrastructural and functional capacity. As on date 55 laboratories are approved or licensed under the provisions of Drugs and Cosmetics Rules, 1945 for quality testing of Ayurvedic, Siddha and Unani drugs and raw materials.
5) In order to promote safe use of AYUSH medicines, the Ministry of AYUSH has signed a MoU with the Advertising Standards Council of India (ASCI) to undertake monitoring of misleading advertisements appearing in the print and TV media and bring the defaulters to the notice of the Central Government and the State Regulators for taking necessary action.
6) The Medical Store In-charges of respective systems of medicine and Medicines Inspection Committee (MIC) randomly check the medicines supplied under Central Government Health Scheme. If the store receives any complaint in respect of any medicine, the supply of that medicine is stopped immediately and process of withdrawal of the issued medicine from dispensary or hospital is started. Samples of medicines are sent for testing to Central Laboratory or NABL accredited /Government approved laboratory.
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7) Powers are vested with the Central Government under Section 33P of the Drugs & Cosmetics Act, 1940 to give directions to the State Governments as and when required for enforcement of the legal provisions related to Ayurvedic, Siddha and Unani drugs.
8) Central Government issued orders to procurement agencies of ASU&H Drugs to obtain batch-wise testing reports of the medicines being procured and supplied to hospitals & dispensaries. States-wise information of testing of drugs and action taken for Spurious/adultered Drugs is provided in Annexure-II.
(e): In order to provide Good Quality AYUSH medicines the Government is providing Grant-in-aid to the States and UTs under National AYUSH Mission (NAM) for augmenting quality control of these drugs, including strengthening of Pharmacies, Drug Testing Laboratories, enforcement framework and testing of drugs.
Further, under the Centrally Sponsored Scheme of National AYUSH Mission (NAM) for providing adequate supply of good quality AYUSH medicines and drugs in the country, following provision has been made:
a) Essential drugs and medicines required for implementation of the Mission will have to be procured from Essential Drugs List (EDL) for Ayurveda, Unani, Siddha and Homoeopathy published by Department of AYUSH, Government of India.
b) At least 50% of the Grant-in aid provided for procurement of medicines should be used for procuring medicines from M/s Indian Medicine Pharmaceutical Corporation Limited (a Central Public Sector Undertaking) or from Public Sector undertakings, pharmacies under State Governments and Co-operatives manufactured in their own manufacturing units and having Good Manufacturing Practices (GMP) compliance, keeping in view the need for ensuring quality of AYUSH drugs and medicines.
c) The remaining Grant-in aid provided under the Mission for purchase of medicines may be used for procuring medicines as per Essential Drugs List (EDL) of Ayurveda, Unani, Siddha and Homoeopathy published by Department of AYUSH, Government of India, from other Good Manufacturing Practices (GMP) compliant units having valid manufacturing licenses.
d) Essential non drug items like dressing items for first aid etc. may be provided out of the amount sanctioned for medicine/ essential drugs under different components required for achieving the desired objectives subject to a ceiling of five percent of the total amount sanctioned for the purpose.
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