Ayurvedic, Siddha and Unani Drugs (DTAB)

Ayurvedic, Siddha and Unani Drugs (DTAB)

Chapter IV A of the Act applies to Ayurvedic, Siddha and Unani Drugs. The related Rules governing activities are from Rules 151 to 167.

Ayurvedic, Siddha and Unani Drugs, Technical Advisory Board.

On lines with DTAB for Allopathic System of Medicines, the Central Government constitutes the Advisory Committee called as Ayurveda, Siddha and Unani Drugs Technical Advisory Board. The Board is required to advise Central and State Governments on all technical matters pertaining to DCA in relation to Ayurvedic, Siddha and unani Tibbi medicines. Major differences as compared to that ofDTAB (Allopathy) are as follows:

1. It consists of only ex-officio and nominated members whereas, in DTAB (allopathy) there are ex-officio, nominated and elected members.

2. There are 20 members as compared to 18 in DTAB (allopathy). This is because 00 systems involved namely Ayurveda, Siddha and Unani.

3. Chariman of this DTAB need not be always Director General of Medical and Health Services, Government ofIndia.

4. The term of this DTAB is for 3 years.

Composition

The Central Government constitutes the Board with 18 members representing different disciplines of Indigenous System of Medicine (Table 8.2). The Central Government nominates one of these members as the Chairman of DTAB. The term is for 3 years. The Headquarters is at Nirman Bhavan, Ministry of Health and Family Welfare, Government of India. The Board meets usually twice a year to discuss on technical matters pertaining to Ayurveda, Siddha and Unani Medicines in relation to DCA. The Central Government appoints Secretary, Assistant-Secretary and other required staff.

Ayurvedic, Siddha and Unani Drugs Consultative Committee

On lines with Drugs Consultative Committee for allopathic drugs, there is a separate Drugs Consultative Committee for Ayurvedic, Siddha and Unani Drugs. 

It is a Statutory Committee charged with the responsibility of advising Central Government and State Government, as well as, Drugs Technical Advisory Board for Ayurveda, Siddha and Unani Drugs on all matters pertaining to uniform implementation of provisions of the Act and Rules in relation to Ayurvedic, Siddha and Unani drug formulations. The Committee comprises of nominated members, two from Central Government and one each from State Government. Drugs Consultative Committee meets as and when required. The Director General of Medical and Health Services is usually the Chairman of Drugs Consultative Committee.

Prohibited from Manufacture

·           No person shall manufacture (i) misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drug and (ii) patent or proprietary medicine unless displayed in prescribed manner with list of ingredients and sell, stock or exhibit any such drug manufactured in contravention with provisions of the Act and Rules. However, Vaidyas and Hakims may manufacture drugs for their own patients.

·           The Central Government reserves power to prohibit, manufacture etc., of Ayurvedic, Siddha or Unani drugs in public interest.

Manufacture of Ayurvedic, Siddha and Unani Drugs

The State Government appoints Licensing Authority for these drugs. Separate application for separate licence for each premises is required to be made.

Form 24-D - Application for grant or renewal oflicence

Form 24-E - Application for Loan Licence

Form 25-D - Issue of licence to manufacture

Form 25-E - Loan Licence for manufacture

Form 35 - Inspection Book to be maintained

Form 48 - Approval for carrying out tests on behalfoflicensee for manufacture

The Good Manufacturing Practices (GMP) for Ayurvedic Drugs have been introduced in 2000. GMP covers requirements of factory premises, equipment for manufacture and analysis, storage, etc.

The licence for manufacture is issued within three months from date of receipt of application. The licence is granted after consulting an expert identified by State Government. The licence for manufacture and Loan licence are valid upto 31st, December of the year following the year in which it is granted or renewed.

The licensee or loan licensee shall maintain proper records of manufacture and analysis, allows Inspector to inspect premises and maintain an Inspection Book in Form 35.

The Licensing Authority, after giving an opportunity to show cause, after 15 days may cancel a licence or suspend it for a specific period, if the licensee fails to comply with conditions of licence. The aggrieved person may appeal to the State Government within 3 months which shall take final decision.

Labelling and Packing

The Label should contain:

(i) Mention ofAyurvedic / Siddha /Unani medicine

(ii) List of ingredients

(iii) Weight, measure or number, as the case may be

(iv) Name and address of manufacturer

(v) Licence number being preceded by the words "Manufacturing Licence Number' or 'MFg. Lic. No.' or 'M.L'.

(vi) For internal use of schedule E (1) drugs on container-, 'Caution-to be taken under medical supervision' both in English and Hindi

(vii) A distinctive batch number

(viii) Date of manufacture

Exemption

Label and packages or containers of Ayurvedic, Siddha and Unani drugs for export may be adapted to meet specific requirements of the law of the country importing such drugs

State Drug Licensing Authority shall have Ayurvedic I Siddha I Unani qualifications as per schedule II of CCIM Act 1970/B. Pharm. (Ayurveda) of a recognized university with minimum five years experience in manufacture or testing of such drugs.

The Government Analyst is one appointed under section 33-F of the Act and shall be a person possessing qualifications prescribed in Rule 44 or a degree in Ayurveda, Siddha and Unani system with minimum of three years of post-graduate experience in analysis of drugs in a laboratory under control of Government Analyst or a Chemical Examiner or Head of approved institution.

The Qualification of Inspector is (i) a degree or diploma in Ayurvedic or Siddha or Unani system or a degree in Ayurvedic Pharmacy or (ii) a qualification laid down under Rule 49 and shall have undergone practical training in manufacture ofAyurvedic, Siddha or Unani drugs.

Standards

The drugs included in Ayurvedic Pharmacopoea have to comply with standards for identify, purify and strength given in it.

Asavas and Aristas have to comply with upper limit of alcohol (self-generated alcohol should not exceed 12 % v/v).