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.
