Regulatary Provisions Regarding Ayurveda, Siddha, Unani and Homoeopathic Medicines <BR><BR>

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Press Information Bureau
Government of India
Ministry of Health and Family Welfare
13-December-2013 13:28 IST

Regulatary Provisions Regarding Ayurveda, Siddha, Unani and Homoeopathic Medicines

Adequate regulatory provisions are available under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 for regulating and monitoring the quality, safety and efficacy of Ayurveda, Siddha, Unani and Homoeopathy medicines in the country.

Licensing Authorities are appointed by the State Governments to oversee the enforcement of legal provisions for the manufacturing of ASU drugs. Guidelines for licensing requirements, Good Manufacturing Practices (GMP) and adherence to standards of drugs as prescribed in the pharmacopoeia are mandatory for the manufacturing of licensed products to ensure quality, safety and efficacy of ASU medicines. Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB) and Ayurveda, Siddha, Unani Drugs Consultative Committee (ASUDCC) are statutory bodies under the Drugs and Cosmetics Act to advise the Central and State Governments on technical matters and for securing uniformity throughout the country in the administration of the Act and Rules thereunder.

The details of laboratories for testing quality of Ayurveda, Siddha, Unani and Homoeopathic (ASU&H) medicines are provided herewith-

Drug Testing Laboratories

(A) List of Central Pharmacopoieal Laboratories

Sr. No.	Name and Address of Central Laboratory
1.	Pharmacopoeial Laboratory for Indian Medicine (PLIM), Ghaziabad (U.P.)
2.	Homoeopathic Pharmacopoeia Laboratory, Ghaziabad (U.P.)

(B) List of Drug Testing Laboratories approved by State Governments under Rule 160A-J of Drugs & Cosmetics Rules, 1945

State/UT	Sr. No.	Name of the Laboratory
Andhra Pr.	1	M/S Varun Herbals Pvt. Ltd., Hyderabad
Delhi	2	M/S Standard Analytical Laboratory Patparganj
	3	M/S SIMA LAB Pvt. LTD. New Delhi
	4	Arbro Pharmaceutical LTD. Kirti Nagar
	5	IT Labs Pvt. LTD. Mongolpuri
	6	Delhi Test House Azadpur
	7	Shri Krishna Analytical Services Mayapuri
Haryana	8	Ozone Pharmaceuticals LTD. Bahadurgarh
	9	M/S International testing centre Panchkula
H.P.	10	M/S Charak Pharmaceuticals Pvt. Ltd., Solan.
	11	M/S Ayurvet Ltd., Solan
	12	M/S Baijnath Research & Development Laboratory, Paprola.
Karnataka	13	Bangalore Test House, Vijay Nagar, Bangalore
	14	Karnataka Anti-Biotics and Pharmaceuticals Ltd., Bangalore
	15	FRLHT, Yelahanka, Bangalore
	16	Natural Remedies Pvt. Ltd., Bangalore
	17	Ramaihah Drugs and Allied products testing lab, Bangalore
	18	KLE Societies Shri BMK Ayurved MAhavidhyalaya, Belgaum
	19	Shiva Analyticals Ltd. ,Bangalore
Kerala	20	M/S Oushadhi, The Pharmaceutical Corporation, Kerala (Recommended for approval in joint inspection but final information from the state regarding its approval is yet to be received)
Madhya Pradesh	21	M/S Shilpachem, Indore (Recommended for approval in joint inspection but final information from the state regarding its approval is yet to be received)
Maharashtra	22	M/S Charak Testing Laboratory Mumbai
Uttarakhand	23	M/S Devansh Testing and Research Lab, Roorkee.
	24	M/S Multani Pharmaceutical Ltd. Roorkee (recommended for approval in joint inspection but final information from the state regarding its approval is yet to be received.)
	25	Indian Medicines Pharmaceutical Corporation Limited (IMPCL) Laboratory, Mohan, Distt Almora.
U.P.	26.	M/S Amar Pharmaceuticals and Lab Pvt Ltd. Kanpur

(C) List of State Govt. Drug Testing Laboratories (DTLs) supported under the Centrally Sponsored Scheme of Quality Control of ASU & H Drugs.

Sr. No.	Name of DTL	Grant Released (Rs.in Lakhs)
1.	Drug Testing Laboratory, Govt. Indian Medicine Pharmacy (Ayu.), Kattedan, Hyderabad, Andhra Pradesh	150.00
2.	Govt. Drug Testing Laboratory, Govt. Central Pharmacy, Jayanagar, I-Block near Ashoka pillar, Bangalore, Karnataka	120.00
3.	Drug Testing Laboratory, Govt. Ayurvedic and Unani Pharmacy Campus, Vazirabad, Nanded, Maharashtra	79.04
4.	Food & Drug Laboratory, near polytechnic, Vadodara, Gujarat.	150.00
5.	Ayurveda Drug Testing Laboratory, Govt. Ayurvedic Pharmacy, Pushkar Road, Ajmer, Rajasthan	141.19
6.	Govt. Analyst Laboratory, Ayurvedic & Unani Medicine, 32-Sarojini Naidu Marg, Lucknow, Uttar Pradesh	130.33
1.	Govt. Drug Testing Laboratory, Joginder Nagar, Distt. Mandi, Himachal Pradesh	121.37
2.	Govt. Drug Testing Laboratory, Rishikul State Ayurvedic College, Haridwar, Uttarakhand	150.00
3.	Ayurvedic Research Institute, Drug Standardization Unit, Poojappura, Thiruvananthapuram, Kerala	150.00
4.	State Drug Testing & Research Laboratory (ISM) Govt. Ayurvedic Hospital Campus, Nagarwartangi, P.O. BJB Nagar. Bhubaneswar, Odisha	100.00
5.	State Pharmacopoeial Laboratory & Pharmacy for Indian Medicine, Kalyani, Nadia, West Bengal	140.00
6.	Food & Drug Testing Laboratory, A-20, Lawrence Road Industrial Area, Delhi	95.00 (Refunded)
7.	Drug Testing Laboratory, Govt. Ayurvedic Pharmacy Compound, Amkho Lashkar, Gwalior, Madhya Pradesh	115.69
8.	Drug Testing Laboratory, Govt. Ayurvedic Pharmacy, GE Road, Raipur, Chhattisgarh	137.60
9.	Combined Food & Drug Laboratory, Patoli, Mangotrian, Jammu & Kashmir	100.00
10.	State Govt. Drug Testing Laboratory for ISM Drugs, Govt. Ayurvedic College, Guwahati, Assam	93.50
11.	State Govt. Drug Testing Laboratory (ISM), Aushadh Niyantran Bhawan, Pt. Nehru Office Complex, Agartala, Tripura	134.63
12.	Govt. Drug Testing Laboratory, Central Medical Store, Zamabawk, Aizawl, Mizoram	175.00
13.	Govt. Drug Testing Laboratory (ISM), Food & Drug Laboratory, Pesteur Institute, Shillong, Meghalaya	88.62
14.	Govt. Drug Testing Laboratory (ISM), Neheralagrum, Itanagar, Arunachal Pradesh	95.00
15.	Govt. Drug Testing Laboratory for AYUSH, Kohima, Nagaland	175.00
16.	Govt. Drug Testing Laboratory, Govt. Central Pharmacy & Store Campus, Old Press Road, Patiala, Punjab	100.00
17.	Govt. Drug Testing Laboratory, (ISM) Sri Krishna Govt. Ayurveda College & Hospital, Kurukshetra, Haryana	100.00
18.	Govt. Drug Testing Laboratory, Ranchi, Jharkhand	100.00
19.	State Govt. Drug Testing Laboratory (ASU), NIPER Mohali, Punjab	50.00 (Refunded)
20.	Govt. Drug Testing Laboratory, Ayurveda and Unani Pharmacy compound, Patna, Bihar	150.00
21.	State Govt. Drug Testing Laboratory for ASU&H drugs, Chander, Sikkim	150.00
22.	Govt. Drug Testing Laboratory for A&S drugs, SASTRA, Thanjavur, Tamil Nadu	85.00
23.	Govt. Drug Testing Laboratory for ISM, Arignar Anna Govt. Hospital of Indian Medicine Complex, Arumbakkam, Chennai, Tamil Nadu	147.03

(D) List of NABL -Accredited Laboratories for testing of ASU/ Herbal / Natural

Drugs.

Sr. No.	State	Name and Contact Details of Laboratories
1	Karnataka	Natural Remedies Research & Development Centre, Plot no. 5, Veerasandra Industrial area,, 19th KM Stone, Hosur Road, Bangalore
2		TUV South Asia Pvt. Ltd., A-151, 2C Main Road, Peenaya Industrial Estate, II Stage, Bangalore-560058
3		Analytical Research and Development Laboratory , Sami Labs Limited , II Phase, Peenya Industrial Estate, Bangalore-560058
4	Tamil Nadu	Drug standardization and Quality Control Lab., Captain Srinivasa Murti Drug Research Institute for Ayurveda, Anna Hospital Campus Arumbakkam, Chennai -600106
5		Asthagiri Herbal Research Foundation, 162 A, II Floor, Perungudi Industrial Estate, Perungudi, Chennai 600096
6		Bureau Veritas Consumer Products Services (India) Private Limited, F2, Thiru-Vi-Ka Industrial Estate, Ekkattuthangal, Guindy, Chennai.
7	Maharashtra	Charak Testing Laboratory, Gala No.32 & 67, Evergreen Industrial Estate. Shakti Mills Lane, Mahalaxmi, Mumbai -400011
8		Geo-Chem Laboratories (P) Ltd., Pragati Building, Adjacent to Crompton Greaves, Kanjur Marg (East), Mumbai – 400042
9		TUV India Pvt. Ltd. (Laboratory Division- Biological), Survey No. 42, Hissa No. 3/1 & 3/2, Village-Sus, Taluka: Mulshi, Pune-411021
10		Ashwamedh Engineers & Consultants co-op so.Ltd, Nashik ( Biological), Survey No.102,Plot No.26, Wadalapathardi Road, Indira Nagar, Near Guru Gobind Singh School , opp. Kanchandeep Lawn, Nashik- 422009
11	Uttar Pradesh	Maharishi Ayurveda Product Pvt. Ltd, Noida, Plot No. 17-18, Noida Special Economic Zone,, Noida G.B. Nagar, U.P.-201305
12		Ashco Niulab Industries Ltd., D - 70, Sector - 2, Noida, Uttar Pradesh
13		Biomass Biology Department, National Botanical Research Institute (NBRI), 2^nd Floor, R. No 205, Rana Pratap Marg, Lucknow- 226 001
14	J & K	Indian Institute of Integrative Medicine (CSIR), Canal Road, Jammu.
15	Delhi	Delhi Test House, A-62/3, G.T. Karnal Road, Industrial Area (Opposite Hans Cinema), Azadpur, Delhi.
16		ARBRO Pharmaceuticals limited, 4 / 9, Kirti Nagar, Industrial Area, New- Delhi - 110015, Delhi.
17		Shriram Institute for Industrial Research , 19 University Road, Delhi.
18	Kerala	Sterling Test House, Uchikkal lane, Poonithura P.O. Cochin-682038.
19	Andhra Pradesh	QPS Bioserve India Pvt. Ltd. (Analytical Division- Biological), D-53, IDA, Phase – 1, Jeedimelta Hyderabad - 500055
20		NCML- CommGrade, Team Towers, Plot No. A-1/2/A, 4th – 6 th Floor, IDA Uppal, Uppal, Hyderabad - 500039
21		Bhagavathi Ana Labs Pvt Ltd (Biological), Central Laboratory, Industrial Estate, Sanath Nagar, Hyderabad- 500018.
22	Haryana	Ozone Pharmaceuticals Ltd.(Analytical Lab), 639-640 MIE, Bahadurgarh.
23	Gujarat	Food & Drugs Laboratories, Near Polytechnic, Vadodara-390002,

The Central Government has established two appellate laboratories- Pharmacopoeial Laboratory for Indian Medicine (PLIM) and Homoeopathy Pharmacopoeia Laboratory (HPL) under the provisions of Drugs & Cosmetics Act, 1940 to test the drug samples referred from Drug Control authorities and other Government authorities. Department of AYUSH has implemented a Centrally Sponsored Scheme to provide financial support to strengthen the State Drug Testing Laboratories. 27 State Drug Testing Laboratories have been supported through the scheme. In addition, legal provision has been made in the Drugs & Cosmetics Rule 160A-J for approval of institutions to carry out testing of Ayurvedic, Siddha and Unani drugs and the raw materials used in these medicines. National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratories have also been allowed to test ASU& H medicines.

This was stated by Smt Santosh Chowdhary, MoS, Ministry of Health and Family Welfare in a written reply to the Lok Sabha today.

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