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Soumya Bajpai
| Updated: 30 May, 2020 | Category: Drug License

Provisions Related to Ayurvedic, Siddha and Unani (ASU) Drugs

ASU drugs

The term “drug” as defined in the Act includes a wide variety of substance, diagnostic, and medical devices. The act defines “cosmetic” as any product that is meant to be applied to the human body for the purpose of beautifying or cleansing. In 1964, the act was amended to include Ayurveda, Siddha, and Unani (ASU) drugs.

Ayurvedic, Siddha and Unani drugs include all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae.  The provision related to the manufacture and control of Ayurvedic, Siddha, and Unani drugs have been prescribed in the Drugs and Cosmetics Act, 1940. The individual section being described here is based on the regulation as prescribed in the Drugs and Cosmetics Act 1940[1], for the Ayurvedic, Siddha and Unani hereinafter ASU drugs.

Drugs and Cosmetics Act 1940

Provisions as amended under Drugs and Cosmetics Act

Central Government has the powers to frame and amend the regulatory provisions and issue a direction to the State Governments for their enforcement. In this regard, the Central Government is advised by the Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB) and Ayurveda, Siddha, Unani Drugs Consultative Committee (ASUDCC), which are statutory bodies under the provisions of Drugs & Cosmetics Act, 1940, in the regulatory matters and enforcement issues respectively pertaining to Ayurvedic medicines.

Sections

Provision related to ASU drugs

 

 

Ayurvedic, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) Section 33-C.

 

  • The Central Government must, 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, Siddha and Unani Drugs Technical Advisory Board) to advise the Central Government and the State Governments on technical matters arising out and to carry out the other functions assigned to it by this Chapter.
  •  The board must be constituted of following members

 

  1. Director General of Health Services, ex officio;
  2. The Drugs Controller, India, ex officio;
  3. The principal officer dealing with Indian systems 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 Government Analyst under section 33F, to be nominated by the Central Government;
  6. One Pharmacognocist to be nominated by the Central Government;
  7. One Phyto-chemist to be nominated by the Central Government;
  8. Four persons to be nominated by the Central Government, 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 Dravyaguna and Bhaishajya Kalpana, to be nominated by the Central Government;
  10. One teacher in ILM-UL-ADVIA and TAKLIS-WA-DAWA-SAZI, to be nominated by the Central Government;
  11. One teacher in Gunapadam, to be nominated by the Central Government;
  12. Three persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be nominated by the Central Government;
  13. Three persons, one each from among the practitioners of Ayurvedic, Siddha and Unani system of medicine, to be nominated by the Central Government.
  • The Central Government has to appoint a member of the Board as its Chairman.
  • The nominated members of the Board must hold office for three years but can be eligible for re-nomination.
  • The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and regulating its own procedure and conduct of all business to be transacted by it.
  • The functions of the Board may be exercised notwithstanding any vacancy therein.
  • The Central Government must appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Government considers necessary.

 

The Ayurvedic, Siddha and Unani Drugs Consultative Committee (ASUDCC) Section 33-D.

  1. To advise the Central Government, the State Governments 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 or Unani drugs.
  2. ASUDCC must consist of two persons to be nominated by the Central Government as representatives of that Government and not more than one representative of each State to be nominated by the State Government concerned.
  3.  ASUDCC must meet when required to do so by the Central Government and must regulate its own procedure.

 

Misbranded drugs Section 33- E.

 ASU drugs are deemed to be misbranded:

  1. If colored, coated, powdered or polished to conceal the damage or made appear better  than therapeutic value than it relay is;
  2. If it is not labeled in prescribed manner;
  3. If label or container or anything accompanying the drug bears any statement, design or device which may makes false claim for the drug or which is false or misleading in any particular

 

Adulterated drugs Section 33-EE.

 ASU drugs are deemed to be adulterated:

  • If it consists, in  whole or in part, of any filthy, putrid or decomposed material;
  • If prepared, packed or stored under unsanitary conditions; 
  • If its container contains any poisonous or deleterious substance color other than one which is prescribed harmful or toxic substance;
  • If it bears or contains, for purpose of coloring,, a color other than prescribed one;
  • If it contains any harmful or toxic substance which may render it injurious to health;
  • If any substance mixed to reduce its quality or strength.

 

Spurious drugs Section 33-EEA.

 

 

 

 

 

 

 

 

 

 

ASU drugs are deemed to be spurious:

  • If it is sold, or offered or exhibited under name of  another name;
  • if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive, or bears upon it or upon its label or container the name of another drug, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug;
  • If the label or container bears the name of an individual or company which is fictitious or does not exist;  
  • If it has been substituted wholly or in part by any other drug or substance;
  • If it purports to be the product of a manufacturer of whom it is not truly a product. 

 

Regulation of manufacture for sale of ASU drugs.  Section 33-EEB.

The person must not manufacture for sale or distribution, any ASU drug except in accordance with such standards, if any, as may be prescribed in relation to that drug.

 

 

Prohibition of manufacture and sale of certain ASU drugs.  Section 33-EEC.

The person  either by himself or by other person on this behalf

  • must not manufacture for sale or distribution
  1. Misbranded, adulterated or spurious ASU drugs
  2. Patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true list of all the ingredients contained in it.
  3. contravention to any of the provisions of this act or any rule  thereunder
  • Sell, stock or exhibit or offer for sale or distribution, any ASU drugs which have been manufactured in contravention of any of the provisions of this act, or any rule made thereunder.
  •  Manufacture for sale or for distribution, any ASU drug, except under, and in accordance with the conditions of, a license issued for such purpose under this chapter.

 

 

Power of Central Government to prohibit the manufacture of ASU drugs in public interest. Section 33-EED.

Central govt., in the public interest, if it is necessary or expedient so to do then, by notification in the Official Gazette,  can prohibit manufacture of ASU drugs, after satisfied on the basis of any evidence or other material available before it that the

  • Drug involve any risk to human beings or animals
  • Drug does not have the therapeutic value claimed

 

 

Government Analysts. Section 33-F.

Central or State government or a state government may, by notification in the official Gazette, can appoint any person, with the prescribed qualification and does not have any financial interest in manufacturing and sale of ASU drugs.

 

Inspectors.  Section 33-G.

 Central or State governments can appoint any person with the prescribed qualification and do not have any financial interest in manufacture or sale of ASU drugs.

 

Penalty for manufacture, sale, etc., of ASU drug in contravention of this Chapter.       Section 33-I.

 Manufactures for sale or for distribution of any ASU drugs deemed to be

  • Adulterated(33-EE), without a valid license as required (33-EEC): one-year imprisonment  or two thousand
  • spurious(33EEA) : one / three years imprisonment  or two/five  thousand

 

Penalty for subsequent offenses.      Section 33-J.

 Whoever having convicted of an offense under 33-I must be punishable with imprisonment for a term not less than two years but which may extend to six years and with fine not less than Rs 5000. (vary as per 33-I section, subsections and clause)

 

Confiscation-Section 33K.

 Any person convicted under the act, the respective stock of ASU drug can be confiscated.

 

Application of provisions to Govt. departments Section 33-L.

 The provision in this chapter except 33-K must apply in relation to manufacture for sale, sale, or distribution of any ASU drugs by any department of government as they apply in relation to the manufacture for sale, sale, or distribution of such drug by any other person.

 

Cognizance of offenses.  Section 33M.

  • No prosecution under this Chapter must be instituted except by an Inspector.
  • No Court inferior to that of a [Metropolitan Magistrate] or of a [Judicial Magistrate] of the first class shall try an offense punishable under this Chapter.

 

Power of Central Government to make rules. Section 33N

The Central Government may –after consultation with, or on the recommendation of, the board( ASUDTAB)- and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter:

In certain circumstances, Govt.  may formulate rules but the board should be consulted within six months.

  • Establishment of ASU laboratories
  • Qualification and duties of Govt. analyst
  • Prescribe method of tests to determine the ingredients of ASU drugs
  • Specify any substance as poison
  • Prescribe forms of licenses for the manufacture for sale of ASU drugs
  • Prescribe conditions to be observed in the packing of ASU drugs
  • Prescribe the conditions for manufacture of small quantity of ASU drugs
  • Prescribe standards of ASU drugs
  • Any other matter which is to be or maybe prescribed under this chapter

 

Power to amend First schedule       Section 33-O

 The central Govt. after consultation with the Board and after giving, by notification in the official gazette, not less than three months’ notice of its intention so to do, may, by a notification, add to or otherwise amend the first schedule.

Read our article:How to get a Manufacturing License of Drugs in India?

Provisions as under Drugs and Cosmetic Rules 1945

The regulatory framework for Ayurvedic medicines is by and large modeled on the lines for allopathic medicines. Drugs & Cosmetics Act, 1940 and Rules thereunder have exclusive provisions for regulation and quality control of Ayurvedic medicines. Regulatory Officers are appointed in the Central and State Governments to oversee the enforcement of legal provisions for Ayurvedic medicines.

Manufacturing of Ayurvedic medicines need Drug license from the concerned State Government as well as compliance to Good Manufacturing Practices (GMP) and the standards prescribed in the Ayurvedic Pharmacopoeia. Proof of safety and effectiveness is required for licensing of various categories of Ayurvedic medicines.

Rules

Provision related to ASU drugs

Manufacture on more than one set of premises Rule 151

 Separate license, for each premises,  is to be obtained for manufacture of  ASU drugs at more than one premises

Licensing authorities Rule 152

 The State Govt. shall appoint licensing authorities by notification in official gazette

Application for license to manufacture ASU drugs Rule 153

 An application for the grant or renewal of a license to manufacture for sale any ASU drugs shall be made in Form 24-D to the Licensing Authority along with a fee of rupees one thousand.

Application for Loan Licence.        Rule 153-A.

 An application for the grant or renewal of a loan license to manufacture for sale of any ASU drugs must be made in Form 25-E to the Licensing Authority along with a fee of rupees six hundred.

Form of license to manufacture ASU drugs: Rule 154.

 Subject to the conditions of rule 157 being fulfilled, a license to manufacture for sale any ASU drugs shall be issued in Form 25-D.

Form of Loan license           

Rule 154 -A

 Subject to the conditions of rule 157 being fulfilled, a license to manufacture for sale any ASU drugs shall be issued in Form 25-E.

Certificate of renewal of license          Rule 155

 The certificate of renewal of a license in Form 25-D must be issued in Form 26 D

Certificate of renewal of Loan license Rule 155 A

 The certificate of renewal of a loan license in Form 25-E must be issued in Form 26 E

 Certificate of award of G.M.P. of Ayurveda, Siddha and Unani Drugs.           Rule 155 B

 Must be issued to licensees who comply with the requirements of GMP of ASU drugs as laid down in Schedule T.

Duration of Licence Rule 156

 An original license in Form 25-D or renewed license in Form 26 –D, unless sooner suspended or canceled, shall be valid for three years from the date of issue or renewed.

Duration of Loan Licence         Rule 156-A

 An original loan license in Form 25-E or renewed license in Form 26 –E, unless sooner suspended or canceled, shall be valid for three years from the date of issue or renewed.

Condition for the grant or renewal of a license in Form 25-D Rule 157

 Conditions as specified in Schedule T

Condition of license  Rule 158

 Licensee must keep proper record, shall allow the inspector, appointed under the Act,  to enter the premises, must maintain the inspection book Form 35

Conditions of loan license           Rule 158-A

 Licensee shall keep a proper record, must allow the inspector, appointed under the Act,  to enter the premises, must maintain the inspection book Form 35

Cancellation and suspension of license Rule 159

 After 15 days show cause to the licensee, in writing, Licensee may appeal within three months

Conclusion

Pharmacopoeia Commission of Indian Medicine & Homoeopathy and Ayurvedic Pharmacopoeia Committee is in place to develop the quality standards and Standard Operating Procedures for Ayurvedic medicines, which are mandatory for the manufacturers to comply with. The Central and State Governments have established Drug Testing Laboratories for Ayurvedic medicines and their raw materials and 55 laboratories so far are approved or licensed in the country in accordance with the Drugs & Cosmetics Rules, 1945 for quality testing of Ayurvedic drug.

Quality certification schemes for Ayurvedic medicines are also administered as per WHO Guidelines and International Standards by Central Drug Standards Control Organization (CDSCO) and Quality Council of India (QCI) respectively.

Read our article:How one can apply for Wholesale Drug License in India?

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Soumya Bajpai

Soumya has done LLB (Hons) and has a 2+years experience in writing. Her main interest is in reading judgments, new enactments and amendments taking around in law. She always strives to bring the best to work that she does.

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