Section 157 in The Drugs and Cosmetics Rules, 1945
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.(1A)[ For issuing of the certificate of Good Manufacturing Practices, the Licensing Authority shall verify the requirements as per Schedule T and issue the Good Manufacturing Practices certificate in Form 26 E-I, simultaneously among with grant or renewal of License in Form 25-D.] [Substituted by Notification No. G.S.R. 376 (E), dated 3.5.2010 (w.e.f. 21.12.1945)](1B)[ No manufacturer shall use any prefix or suffix with the name of any Ayurvedic, Siddha or UnaniTibb drug falling under clause (a) of section 3 of the Act, except as described in the authoritative books specified in the First Schedule to the Act:Provided that a formulation without any specific name, described in the authoritative books may be named on the basis of the ingredients of that formulation.(1C)The name of any Ayurvedic, Siddha or UnaniTibb drug falling under clause (a) of section 3 of the Act shall not be used for naming any patent or proprietary medicine relating to Ayurvedic, Siddha or UnaniTibb systems of medicine referred to in sub-clause (i) of clause (h) of the said section:Provided that this rule shall not be applicable for single plant-ingredient based Ayurvedic, Siddha or UnaniTibb formulation licensed or to be licensed as patent or proprietary medicine under sub-clause (i) of clause (h) of section 3 of the Act .(1D)Notwithstanding the period for renewal of license provided in rules 156 and 156A, the licensee of the Ayurvedic, Siddha or UnaniTibb drug, which is not in conformity with sub-rules (1B) and (1C), shall seek renewal of the license with appropriate name of the drug within a period of one year from the date of commencement of the Drugs and Cosmetics (4thAmendment) Rules, 2015:Provided that this rule shall not be applicable to any batch of Ayurvedic, Siddha or UnaniTibb drugs manufactured prior to the date of commencement of the Drugs and Cosmetics (4thAmendment) Rules, 2015.(1E)Whoever contravenes the provisions of rules (1B) to (1D) shall be punishable under section 33-I of the Act.] [Substituted for sub-rules (1B) and (1C) by Notification No. G.S.R. 390(E), dated 18.5.2015 (w.e.f. 21.12.1945)](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:-(a)a degree in Ayurvedic or Ayurveda Pharmacy, Siddha or Unani system of medicine, as the case may be, conferred by a University, a State Government or Statutory Faculties, Councils and Boards of Indian Systems of Medicine recognized by the Central Government or a State Government for this purpose, or(b)a diploma in Ayurvedic, Siddha or Unani system of medicine granted by a State Government or an Institution recognized by the Central Government for this purpose, or(c)a graduate in Pharmacy or Pharmaceutical Chemistry or Chemistry or Botany of a University recognized by the Central Government 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 systems 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 Government.(3)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.
