Drugs and Cosmetics (Amendment) Rules, 2020. : Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy MINISTRY OF AYURVED...
New Delhi, the 30th September, 2020
1. (1) These rules may be called the Drugs and Cosmetics (….Amendment) Rules, 2020.
(2) They shall come into force from the date of their final publication in the Official Gazette.
In the Drugs and Cosmetics Rules, 1945, under PART II, rule 3A(7) and under PART XVIII, rules 163A to 163G, 164, 165, 166, 167 and related Form 1A, Form 2A and Schedule B, the following shall be substituted, namely:-
I. In, Rule 3A(7) shall be omitted
II. In PART XVIII, before Rule 163-A, title ‘Pharmacopoeia Commission of Indian Medicine & Homoeopathy and Central Drugs Laboratory of Indian Medicine and Homoeopathy’ shall be inserted followed by -
163-A. Pharmacopoeia Commission of Indian Medicine & Homoeopathy at Ghaziabad (Uttar Pradesh)
under the Central Government shall function to develop and amend standards of Ayurvedic, Siddha, Unani and Homoeopathy drugs and publish pharmacopoieal monographs, formularies and standardized procedures with the approval of Central Government. Laboratory of the Pharmacopoeia Commission shall be the Central Drugs Laboratory for Indian Medicine & Homoeopathy for the purpose of testing or analysis of Ayurveda, Siddha, Unani and Homoeopathy Drugs.
163-B. (1) The Central Government shall, by notification in the Official Gazette and with effect from such date as may be specified therein, constitute Scientific Advisory Board for the Pharmacopoiea Commission of Indian Medicine & Homoeopathy for a term of three years, to advise the Central Government, the State Governments and the stakeholders on the matters of standards, standard operating procedures and testing protocols of Ayurveda, Siddha, Unani and Homoeopathy Drugs.
(2) The Scientific Advisory Board shall consist of the following members, namely:-
- (i) Retired Scientific Expert of drugs to be nominated as Chairman by the Central Government;
- (ii) Director, Pharmacopoiea Commission of Indian Medicine & Homoeopathy; ex officio Member Secretary
- (iii) Advisor dealing with drugs, Ministry of AYUSH, ex officio;
- (iv) Drugs Controller General, India, ex officio;
- (v) Scientific Director, Indian Pharmacopoeia Commission, ex officio;
- (vi) Director General, Central Council for Research in Ayurvedic Sciences, ex officio;
- (vii) Director General, Central Council for Research in Unani Medicine, ex officio;
- (viii) Director General, Central Council for Research in Siddha, ex officio;
- (ix) Director General, Central Council for Research in Homoeopathy, ex officio;
- (x) Central Government Analyst for Ayurveda, Siddha, Unani and Homoeopathy Drugs, ex officio;
- (xi) One professionally experienced expert each of standardization or quality control of Ayurveda, Siddha, Unani, Homoeopathy drugs, pharmacognosy or botany, chemistry, Phyto-chemistry and pharmacy to be nominated by the Central Government from amongst the scientific institutions.
- (xii) Chairman shall have the discretion to co-opt two experts for advice and guidance in specific matters of standards of Ayurvedic, Siddha, Unani and Homoeopathy drugs.
(3) The functions of Scientific Advisory Board may be exercised notwithstanding any vacancy therein.
(4) The Commission shall constitute a pharmacopoeia committee and sub-committees there under for a period of three years on the recommendation of Scientific Advisory Board.
(5) The meetings of Scientific Advisory Board, Pharmacopoeia Committee and Sub-committees shall be supported by the Commission.
163-C. (1) The laboratory of Pharmacopoeia Commission of Indian Medicine & Homoeopathy shall act as Central Appellate Drugs Laboratory under section 6 of the Act for testing or analysis of samples of Ayurveda, Siddha, Unani and Homoeopathy Drugs as may be sent to it under section 11(2) or section 25 (4) and 33-H of the Act;
(2) The Central Drugs Laboratory shall maintain reference museum and herbarium of Ayurveda, Siddha, Unani and Homoeopathy drugs, conduct training programmes for analytical and drugs quality control methods and carry out such activities and duties as may be entrusted to it by the Central Government.
(3) All functions of the Central Drugs Laboratory for Ayurvedic, Siddha, Unani and Homoeopathy drugs shall be exercised by the Director or the officer appointed on his behalf of the Pharmacopoeia Commission of Indian Medicine & Homoeopathy.
163-D. Despatch of samples for test or analysis - (1) Samples for testing or analysis of Ayurveda, Siddha, Unani and Homoeopathy drugs under Sub-section (2) of Section 11 or sub-section (1) of section 25 and section 33-H of the Act shall be sent by registered post in a sealed packet, enclosed with a memorandum in Form1A / Form 18, as the case may be, specified in Schedule A , in an outer cover addressed to the Director, Pharmacopoeia Commission of Indian Medicine & Homoeopathy, Ghaziabad (Uttar Pradesh).
(2) The packet as well as the outer cover of the drug sample shall be marked with a distinguished number.
(3) A copy of the memorandum in Form 1A / Form 18 and a specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director, Pharmacopoeia Commission of Indian Medicine & Homoeopathy, Ghaziabad (Uttar Pradesh)..
163-E. Recording of condition of seals- On receipt of the packet of drug sample, it shall be opened by an officer authorized in writing on that behalf by the Director, Pharmacopoeia Commission for Indian Medicine & Homoeopathy, who shall record the condition of the seal on the packet.
163-F. Report of result of test or analysis- After test or analysis, the result of the test or analysis, together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2A or Form 13, as the case may be, as specified in the said schedule.
163-G. Fees -The fees for test and analysis of drug sample shall be as specified in Schedule B-1
163-H Signature on certificates-Certificates issued under these rules by the Central Drugs Laboratory of Indian Medicine & Homoeopathy shall be signed by the Director or by an officer authorized by the Central Government to sign such certificates.
164. Method of test or analysis to be employed in relation to Ayurveda , Siddha, Unani or Homoeopathy Drugs.—The method of test or analysis to be employed in relation to an Ayurveda, Siddha, Unani or Homoeopathy Drug shall be such as may be specified in the Ayurvedic or Siddha or Unani or Homoeopathic Pharmacopoeia, or if no such tests are specified in the pharmacopoeias, such tests as the Government Analyst may employ, as are scientifically established to determine whether the drug contains the ingredients as stated on the label.
165. Qualifications of Government Analyst.—A person who is appointed as Government Analyst under section 33 F of the Act shall be a person possessing the qualifications prescribed in Rule 44 or postgraduate qualification in Ayurvedic Ras-shastra/Unani Saidala/ Siddha Marunthu- Alunur/pharmacy or degree qualification of Ayurveda/Unani/Siddha/ Homoeopathy recognized by the Central Government with not less than three years experience in the analysis of drugs in a laboratory under the control of (i) a Government Analyst appointed under the Act, or (ii) a Chemical Examiner to Government, or (iii) the Head of an institution specially approved for the purpose by the appointing authority.
166. Duties of Government Analyst– (1) The Government Analyst shall analyze or test or cause to be analyzed or tested such samples of Ayurvedic, Siddha, Unani or Homoeopathy drugs as may be sent to him by Inspectors or any other persons or authority authorized by the Central Government or State Government under the provisions of the Act and shall furnish reports of the results of test or analysis in accordance with these rules.
(2) A Government Analyst appointed under section 33F shall from time to time forward to the Government reports giving the result of analytical work and research with a view to their publication at the discretion of the Government.
167. Qualifications of Inspectors.–A person who is appointed an Inspector under section 33G of the Act shall be a person who—
(a) has the qualifications laid down under rule 49 and shall have undergone practical training in the manufacture of Ayurvedic, Siddha, Unani or Homoeopathy drugs, as the case may be; or
(b) has undergone degree course in Ayurveda, Siddha, Unani or Homoeopathy recognized by the Central Government or degree course of pharmacy in Ayurveda, Unani, Siddha or Homoeopathy, as the case may be, conferred by University or State Government...................... Read More
Source : http://egazette.nic.in/WriteReadData/2020/222235.pdf