- Provisions relating to (Ayurvedic, Unani & Siddha Drugs)
- Manufacture for sale of ayurvedic (including siddha) or unani drugs
- Labelling, Packing and limit of alcoho in ayurvedic (including siddha ) or unani drugs
- Government analysis and inspectors for ayurvedic (including siddha) or unani drugs
Ayurvedic, Unani & Siddha Drugs Technical Advisory Board
1) The Central Government shall, by notification in the Official Gazette and with effect from such date as may be specified therein, constitute a Board(to be called the {Ayurvedic, Unani & Siddha Drugs Technical Advisory Board}) to advise the Central Government and the State Governments on technical matters arising out of this chapter and to carry out the other functions assigned to it by this chapter.
A) The Board Shall consist of the following members, namely:
1) The Director-General of Health Services, ex officio;
2) The Drugs Controller, India, ex officio;
3) The principal officer dealing with Indian system of medicine in the Ministry of Health, ex officio;
4) The Director of the Central Drugs Laboratory, Calcutta, ex officio;
5) One person holding the appointment of Govt. Analyst under section 34-F, to be nominated by the Central Govt.;
6) One Pharmacognocist to be nominated by Central Govt.;
7) One Phyto-chemist to be nominated the Central Govt.
8) Four persons to be nominated by Central Govt., two from amongst the members of the Ayurvedic Pharmacopoeia Committee, one from amongst the members of the Unani Pharmacopoeia Committee and one from amongst the members of the Siddha Pharmacopoeia Committee;
9) One teacher in Darvyaguna, and Bhaishajya Kalpana, to be nominated by the Central Government;
10) One teacher in ILM-UL-ADVIA and TAKLIS-WA DAWASZAI, to be nominated by the Central Government;
11) One teacher in Gunapadam to be nominated by Central Government;
12) Three persons, one each to represent the Ayurvedic, Siddha & Unani drug industry, to be nominated by the Central Government;
13) Three persons, one each from among the practitioners of Ayurvedic, Siddha & Unani Tibb systems of medicine to be nominated by the Central Government;
14) Three persons, one each from among the practitioners of Ayurvedic, Siddha & Unani Tibb systems of medicine to be nominated by the Central Government.
B)
1) The Central Govt. shall appoint a member of the Board as its Chairman.
2) The nominated members of the Board shall hold office for three years but shall be eligible for renomination.
3) The Board may, subject to the previous approval of Central Govt. make bye-laws fixing a quorum and regulating its own procedure and conduct of all business to be transacted by it.
4) The functions of the Board may be exercised not withstanding any vacancy therein.
5) The Central Govt. shall appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Govt. considers necessary.
The Ayurvedic, Siddha & Unani Durgs Consultative Committee.
1) The Central Govt. may constitute an advisory committee to be called the Ayurvedic, Siddha and Unani Drugs Consultative Committee to advise the Central Govt., the State Govt. and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board on any matter for the purpose of securing uniformity throughout India in the administration of this Act in so far as it relates to Ayurvedic, Siddha and Unani Drugs.
2) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two persons to be nominated by the Central Govt. as representatives of that Govt. and not more than one representative of each State to be nominated by the State Govt. concerned.
3) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall meet when required to do so by the Central Govt. and shall regulate is own procedure.
Manufacture for Sale of Ayurvedic (Including Siddha) or Unani Drugs
151. Manufacture on more than one set of premises:- If Ayurvedic (including Siddha) or Unani drugs are manufactured on more than one set of premises, a separate application shall be made and a separate license shall be obtained in respect of each such set of premises.
152. Licensing authorities: For the purpose of this part the State Govt. shall appoint such licensing authorities and for such areas as may be specified in this behalf by notification in the Official Gazette.
153. Application for license to manufacture Ayurvedic (including Siddha) or Unani Drugs. (i) An application for the grant or renewal of a license to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 24-D to the licensing authority along with a fee of rupees sixty:
Provided that in case of renewal the applicant may apply for the renewal of the license before its expiry or within one month of such expiry.
Provided further that the applicant may apply for renewal after the expiry of one month but within three months of such expiry in which case of fee payable for renewal of such license shall be rupees sixty plus additional fee of rupees thirty.
(ii). A fee of rupees fifteen shall be payable for a duplicate copy of a license issued under this rule, if the original license is defaced, damaged or lost.
153-A. Loan License:- (i) An application for the grant or renewal of loan license to manufacture for sale of any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 25-E to the licensing authority along with a fee of rupees thirty. Explanation - For the purpose of this rule, a loan license means a license which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but intends to avail himself of the manufacturing facilities owned by a licensee in Form 25-D:
Provided that in the case of renewal the applicant may apply for the renewal of the license before its expiry or within one month of such expiry:
Provided that in the case of renewal the applicant may apply for the renewal one month, but within three months of such expiry in which case the fee payable for renewal of such license shall be rupees thirty plus an additional fee of rupees fifteen.
(ii) A fee of rupees seven and paise fifty shall be payable for a duplicate copy of a license issued under this rule, if the original license is defaced, damaged or lost.
154. Form of license to manufacture Ayurvedic (including Siddha) or Unani drugs. (1) Subject to the conditions of Rule 157 being fulfilled, a license to manufacture for sale any Ayurvedic (including Siddha)or Unani system shall be issued in Form 25-D. The license shall be issued within a period of three months from the date of receipt of the application.
(2) A license under this rule shall be granted by the licensing authority after consulting such expert in Ayurvedic (including Siddha) or Unani system of medicine, as the case may be, which the State Govt. may approve in this behalf.
154-A. - Form of loan license to manufacture for sale Ayurvedic, Siddha or Unani drugs. (1) A loan license to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25-E.
(2). A license under this rule shall be granted by the licensing authority after consulting such expert in Ayurvedic (including Siddha) or Unani system of medicine, as the case may be, which the State Govt. may approve in this behalf.
(3) The licensing authority shall, before the grant of a loan license. Satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan license.
155. Certificate of renewal. - The certificate of renewal of a license in Form 25-D shall be issued in Form 26-D.
155-A. Certificate of renewal of a loan license. - The certificate of renewal of a loan license in Form 25-E shall be issued in Form 26-E.
156. Duration of license. - An original license in Form 25-D or a renewal license in Form 26-D, unless sooner suspended or cancelled shall be valid up to the 31st December, of the year following the year in which it is granted or renewal:
Provided that if the application for the renewal of a license is made before is expiry or within one month of its expiry, or if the application is made within three months of its expiry after payment of the additional fee of rupees thirty, the license shall continue to be in force until orders are passed on the application. The license shall be deemed to have expired, if application for its renewal is not made within three months of its expiry.
156-A. Duration of loan license. - An original loan license in Form 25-E or a renewed loan license in Form 26-E, unless sooner suspended or cancelled, shall be valid up to the 31st December of all year following the year in which it is granted or renewed:
Provided that if the application for the renewal of a loan license is made in accordance with Rule 153-A, the loan license shall continue to be in force until orders are passed on the application. The license shall be deemed to have expired, if application for its renewal is not made within three months of its expiry.
157. Conditions for the grant or renewal of a license in Form 25-D - Before a license in Form 25-D is granted or renewed in Form 26-D the following conditions shall be complied with by the applicant, namely:-
1. The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be carried out in such premises and under such hygienic conditions as are specified in schedule T.
2. The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be conducted under the direction and supervision of competent technical staff consisting at least of one person, who is a whole-time employee and who possesses the following qualifications, namely:
1.(a) A degree in Ayurveda or Ayurvedic Pharmacy, Siddha or Unani systems of medicine, as the case may be, conferred by a University, a State Govt. or Statutory Facilities, Councils and Boards of Indian Systems of Medicine recognized by the Central Govt. or a State Govt. for this purpose, or
(b) A diploma in Ayurveda, Siddha or Unani System of medicine granted by a State Govt. or an Institution recognized by the Central Govt. for this purpose.
(c). A graduate in Pharmacy or Pharmaceutical Chemistry or Chemistry or Botany of a University recognized by the Central Govt. with experience of at least two years in the manufacture of drugs pertaining to the Ayurvedic or Siddha or Unani system of medicine, or
(d). A Vaid or Hakim registered in a State Register of Practitioners of indigenous system of medicines having experience of at least four years in the manufacture of Siddha or Unani drugs, or
(e). A qualification as Pharmacist in Ayurvedic (including Siddha) or Unani system of medicine, possessing experience of not less than eight years in the manufacture of Ayurvedic or Siddha or Unani Drugs as may be recognized by the Central Govt.
(2). The competent technical staff to direct and supervise the manufacture of Ayurvedic drugs shall have qualifications in Ayurveda and the competent technical staff to direct and supervise the manufacture of Siddha drugs and Unani drugs shall have qualifications in Siddha or Unani, as the case may be.
158. Conditions of license. - A license in Form 25-D shall be subject to the conditions stated therein and to the following further conditions, namely:
(a). The license shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or by any other person on his behalf, of the raw materials and finished products.
(b). The license shall allow an Inspector appointed under the Act to enter any premises where the manufacture of a substance in respect of which the license is issued is carried on, to inspect the premises, to take samples of the raw materials as well as the finished products, and to inspect the records maintained under these rules.
(c). The license shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.
158-A. Conditions of loan license. - A license in Form 25-E shall be subject to the following further conditions, namely:
(a). The license in Form 25-E shall be deemed to be cancelled or suspended, if the license owned by the licensee in Form 25-D whose manufacturing facilities have been availed of by the license is cancelled or suspended, as the case may be, under these rules.
(b). The licensee shall comply with the provisions of the Act and of the rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IV-A of the Act, provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette.
(c). The licensee shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or any other person on his behalf, of the raw materials and finished products.
(d). The licensee shall allow an Inspector appointed under the Act to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose the ascertaining whether the provisions of the Act and the rules have been observed.
(e). The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.
159. Cancellation and suspension of licenses. - (1) The licensing authority may, after giving the licensee an opportunity to show cause, within a period which shall not be less than fifteen days from the date of receipt of such notice, why such an order should not be passed, by an order in writing stating the reasons therefore, cancel a license issued under this part or suspend it for such period as he thinks fit, either wholly or in respect of some of the drugs to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the license or with any provisions of the Act or the rules made there under.
(2) A licensee whose license has been suspended or cancelled may appeal to the State Government within a period of three months from the date of receipt of the order, which shall, after considering the appeal, decide the same.
160. Identification of raw materials - Raw material used in the preparation of Ayurvedic (including Siddha) or Unani drugs shall be identified and tested, wherever tests are available for their genuineness, and records of such tests as are carried out for the purpose and the methods thereof shall be maintained.
Labelling, Packing and limit of Alcoho in Aurvedic (Including Siddha ) or Unani drugs
161. Labeling, packing and limit of alcohol - (1) There shall be conspicuously displayed on the label of the container or package of an Ayurvedic (including Siddha) or Unani drug, the true list of all the ingredients used in the manufacture of the preparation together with the quantity of each of the ingredients incorporated therein and a reference to the method of preparation thereof as detailed in the standard text and Adikarana, as are prescribed in the authoritative books specified in the First Schedule of the Act.
Provided that if the list of ingredients contained in the medicine is large and cannot be accommodated on the label, the same may be printed separately and enclosed with the packing and reference be made to this effect on the label.
(2) The container of a medicine for internal use made up ready for the treatment of human ailments shall, if it is made up from a substance specified in Schedule E(I), be labelled conspicuously with the words 'Caution: to be taken under medical supervision' both in English and Hindi languages.
(3) Subject to the other provisions of these rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Ayurvedic (including Siddha) or Unani drug and on any other covering in which the container is packed, namely:
(i). The name of the drug. For this purpose the name shall be the same as mentioned in the authoritative books included in the First Schedule of the Act.
(ii). A correct statement of the net content in terms of weight-measure or number as the case may be. The weight and volume shall be expressed in metric system.
(iii). The name and address of the manufacturer.
(iv). The number of the license under which the drug is manufactured, the figure representing the manufacturing license number being preceded by the words 'Manufacturing License Number' or 'Mfg. Lic. No.' or 'M.L.'
(v). A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figure representing the batch number being preceded by the words 'Batch No.' or 'Bath' or 'Lot Number' or
(vi). The date of manufacture. For this purpose the date of manufacture shall be the date of completion of the final products, or the date of bottling or packing for issue.
(vii). The works "Ayurvedic medicine" or "Siddha medicine" or "Unani medicine" as the case may be.
(viii). The words "FOR EXTERNAL USE ONLY" if the medicine is for external application.
(ix). Every drug intended for distribution to the medical profession as a free sample shall, while complying with the labeling provisions under clauses (i) to (viii), further bear on the label of the container the words "Physician's sample. Not to be sold" which shall be overprinted.
(4) Nothing in these rules shall be deemed to require the labeling or any transparent cover or of any wrapper-case or other covering used solely for the purpose of packing, transport or delivery.
Government Analysis and Inspectors for Ayurvedic (Including Siddha) or Unani drugs
162. Duties of Inspectors specially authorised to inspect to manufacture of Ayurvedic (including Siddha) or Unani drugs. - Subject to the instruction of the controlling authority, it shall be the duty of an Inspector authorised to inspect the manufacture of Ayurvedic (including Siddha) or Unani drugs:
i). To inspect not less than twice a year, all premises licensed for manufacture of Ayurvedic (including Siddha) or Unani drugs within the area allotted to him and to satisfy himself that the conditions of the license and the provisions of the Act and the rules made thereunder are being observed;
ii). To sent forthwith to the controlling authority after each inspection a detailed report indicating whether or not the conditions of the license and the provisions of the Act and the rules made thereunder are being observed;
iii). To take samples of the drugs manufactured on the premises and send them for test or analysis in accordance with these rules;
iv). To institute prosecutions in respect of violation of the Act and the rules made thereunder.
163. Procedure for dispatch of sample to Government Analyst and its receipt by the Government Analyst (1) Sample for test or analysis shall be sent to the Govt. Analyst by registered post or by hand in a sealed package, enclosed together with a memorandum in Form 18-A in an outer cover addressed to the Govt. Analyst.
1. The package as well as the outer cover shall be marked with a distinguishing number.
2. A copy of the memorandum and specimen impression of the seal used to seal the package shall be sent by registered post or by hand to the Govt. Analyst.
3. On receipt of the package from an Inspector, the Govt. Analyst or an Officer authorised by him in writing in this behalf shall open the package and shall also record the conditions of the seals on the package.
4. After the test or analysis has been completed, one copy of the results of the test or analysis shall be supplied forthwith to the sender in Form 13-A. A copy of the result in Form 13-A shall be sent simultaneously to the controlling authority and to the Drugs Controller, India.
164. Method of test or analysis to be employed in relation to Ayurvedic (including Siddha) or Unani drugs. - The method of test or analysis to be employed in relation to an Ayurvedic (including Siddha) or Unani Pharmacopoeia, or if no such pharmacopoeias are available or if no tests are specified in such pharmacopoeias, such tests as the Govt. Analyst may employ, such test being scientifically established to determine whether the drug contains the ingredients as stated on the label.
165. Qualification of Government Analyst. - A person who is appointed a Government Analyst under Section 33-Fof the Act shall be a person possessing the qualifications prescribed in Rule 44 or a degree in Ayurveda, Siddha or Unani system, as the case may be, conferred by a University, a State Govt. or Statutory Faculties, Councils and Boards of Indian Systems of Medicine recognized by the less than three years post-graduate experience in the analysis of drugs in a laboratory under the control of (i) a Govt. Analyst appointed under the Act, or (ii) a Chemical Examiner to Govt., or (iii) the head of an institution specially approved for the purpose by the appointing authority.
166. Duties of Government Analyst. - (1) The Govt. Analyst shall analys or test or cause to be analysed or tested such samples of Ayurvedic (including Siddha) or Unani drugs as may be sent to him by Inspectors or any other persons or authority authorised by the Central Govt. or a State Govt. under the provisions of Chapter IV-A of the Act and shall furnish reports of the results of test or analysis in accordance with these rules.
(2) A Govt. Analyst appointed under Section 34-F shall from time to time forward to the Govt. reports giving the results of analytical work and research with a view to their publication at the discretion of the Government.
167. Qualification of Inspector - A person who is appointed an Inspector under Section 33-G 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 (including Siddha) or Unani drug, as the case may be; or
b. has a degree in Ayurvedic or Siddha or Unani System or a degree in Ayurveda Pharmacy, as the case may be, conferred by a University or a State Govt. or a Statutory Faculty, Council or Board of Indian Systems of Medicine recognized by the Central Govt. or the State Govt. for this purpose; or
c. has a diploma in Ayurveda, Siddha or Unani Systems, as the case may be, granted by a State Govt. or an Institution recognized by the Central Govt. or a State Govt. for this purpose.
