Question : Drug Testing Laboratories in AYUSH

Will the Minister of AYURVEDA, YOGA AND NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) be pleased to state:

(a) whether inadequate number of drug testing laboratories for AYUSH is one of the major reasons for circulation of spurious AYUSH drugs in the country;

(b) the number of drug testing laboratories for AYUSH functioning and proposed to be opened in the country, State/ UT-wise;

(c) the quantum of funds allocated for this purpose during the last three years and the current year;

(d) the mechanism in place to review the functioning of drug testing laboratories for AYUSH;

(e) whether the Government proposes to launch a campaign to create awareness and ensure public participation against spurious drugs, if so, the details thereof; and

(f) the steps taken/being taken by the Government to revamp the drug testing laboratories of AYUSH in the country?

Answer given by the minister

ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA,
YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY
(SHRI SHRIPAD YESSO NAIK)
(a) & (b): The government has supported 27 State Drug Testing Laboratories have been supported under the Quality Control Scheme of Ayurveda, Siddha, Unani & Homoeopathy drugs under National AYUSH Mission. 58 private Drug Testing Laboratories have also been approved under the Drugs and Cosmetics Rules 1945 for the testing of ASU&H drugs in the Country. In addition there are two central Drug Testing Laboratories i.e. Pharmacopoeial Laboratory for Indian Medicines (PLIM) & Homeopathic Pharmacopoeia Laboratory (HPL), Ghaziabad which is appellate laboratory under the Drugs and Cosmetics Rules 1945. Provisions for regulation and quality control of Ayurvedic and Unani medicines being manufactured for sale in the country are prescribed in the Drugs & Cosmetics Act, 1940 & Rules 1945. These provisions are enforced by the Licensing Authorities & Drug Control Officers appointed by the State Governments. As the spurious Ayurvedic and Unani medicines are defined in Section 33-I of the Drugs & Cosmetics Act, 1940 along with the penalty provisions, accordingly the defaulters can be punished with monitory fine and imprisonment for a term up to three years as determined by the court.
(c) &(d): Under the National AYUSH Mission the funds allocated for quality control Scheme of ASU&H drugs during last 03 years and the current year is enclosed at Annexure. Government has constituted Central monitoring Team to review the physical and financial progress and functionality of State Drug Testing Laboratories and pharmacies of ASU drugs in time to time.
(e) & (f): In order to create awareness and ensure public participation against spurious drugs the government has conducted 07 training programmes for strengthening of all States/UTs of State regulatory staff ASU drug manufacturing units Drug Testing Laboratories of AYUSH drugs. Following other steps have also been taken:-
1. Pharmacopoeial Laboratory for Indian Medicines & Homoeopathic Pharmacopoeia Laboratory, Ghaziabad are conducting training programs of the State Regulators, In-charges of Drug Testing Laboratories, Pharmacies in every year.
2. States/UTs have been directed to constitute an expert committee for examination of License applications vide order dated 12.02.2019 and to appoint controlling Authorities for the State Licensing Authority & Inspectors.
3. e-aushadi portal has been developed for online submission and disposing of license applications and certificates of the ASU&H Drug manufacturers.
4. Ministry of AYUSH notified creation of 09 regulatory posts on 24-07-2019 including the posts of Deputy Drugs Controllers (01), Assistant Drugs Controllers (04) (one each for Ayurveda, Homoeopathy, Unani and Siddha drugs) and Drug Inspectors (04) (one each for Ayurveda, Homoeopathy, Unani and Siddha drugs) as approved by the Department of Expenditure vide ID No. 1141843/E.Coord.I/2019 dated 12.07.2019. Recruitment Rules for these posts are being finalized in consultation with Department of Personnel & Training (DoPT), Union Public Service Commission (UPSC) and Law Ministry to initiate the recruitment of regular incumbents. Meanwhile, the posts have been operationalized by giving additional charge to the existing Technical Officers of the Ministry of AYUSH.
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