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Chapter 1: About Drugs in General    
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OTC DRUGS : SOME LEGAL ASPECTS
 

'OTC Drugs' in common parlance means drugs which are legally allowed to be sold Over the Counter without the prescription of a Registered Medical Practitioner. The term is clumsy and creates a wrong impression about the official status of the drugs. In India, import, manufacture for sale and the sale and distribution of drugs and cosmetics is regulated by the Drugs and Cosmetics Act, 1940 and its subordinate legislation Drugs and Cosmetics Rules, 1945. The phrase 'Over The Counter' and its abbreviation 'OTC' preparations have no legal recognition and are better referred to as 'non-prescription drugs' and/or as 'household remedies'.

Identification of OTC Drugs: Since the phrase has no legal recognition, OTC drugs have to be identified by reductio ad absurdum logic. It may be said that the current drug laws specify prohibitions - drugs which must not be given without a valid prescription. What is not prohibited is permitted. Thus, all the drugs which are not specified in the list of 'prescription drugs' must be considered as non-prescription drugs (or the OTC drugs).

Identification of 'Prescription Drugs': 'Prescription drugs' fall under two schedules of the Drug Rules, 1945 - Schedule H and Schedule X. The latter consists of habit forming, abusable drugs requiring double prescription.

The containers of the preparations containing Schedule H or Schedule X drugs must conspicuously display on the label the following warning: "To be sold by retail on the prescription of a Registered Medical Practitioner only".

The left top corner of the container is marked by any one of the following symbols:

  a)  

'RX' for - Preparations containing Schedule H drugs.

  b)   'NRX' (in red colour) for - Preparations containing Schedule H drugs which also come within
      the purview of the `Dangerous Drugs Act'.
  c)   'XRX' (in red colour) for - preparations containing Schedule X substances.

Some preparations are not included in Schedule H or X. Yet, in public interest, administrative instructions are given to the manufacturers that their labels carry the same warning as for Schedules H or X viz. "Warning: To be Sold by Retail on the Prescription of a Registered Medical Practitioner Only".

There are yet some preparations, though available without prescription, contain Schedule G substances. They need to have a cautionary note as follows - "Caution - it is dangerous to take this preparation except under medical supervision".

Premises for the Sale of Drugs: There are three types of licensed premises and they display on the board the appropriate description viz. (a) pharmacy/pharmacist/dispensing chemist/pharmaceutical chemist, (b) chemists and druggists or (c) drug store.
 


(a)

Pharmacy/Pharmacist/Dispensing Chemist/Pharmaceutical Chemist: In such premises

   i) Pharmacy is maintained for compounding against prescriptions.
  ii) Supervision of a qualified person is obligatory.
  iii) All types of drugs (OTC as well as prescription drugs) are supplied.
(b) Chemists and Druggists : In such premises
  i) Pharmacy is not maintained, so compounding is not permitted
  ii) Supervision of a qualified person is obligatory
  iii) All types of drugs (OTC as well as prescription drugs) are supplied.
(c) Drug Stores: In such premises only non-prescription drugs (OTC drugs) are available. Services of qualified person are not obligatory. Supply of prescription drugs and compounding is not permitted.

Decision Makers

The Drugs and Cosmetics Rules 1945 can be amended by the Government of India. A draft of amendment along with reasons are prepared by the Government (Drugs Controller of India) and sent for approval of the Drugs Technical Advisory Board (DTAB). After approval of the Board, it is approved by the Ministries of Health and Law. It is then published in the Gazette notification and suggestions invited from those affected by it. Suggestions are considered and if required, the rules amended suitably.

The DTAB has thus a crucial role to play in the process of amendment, as its approval is obligatory. If prior approval is not possible in emergency cases, then the approval of the board has to be taken within six months. The board consists of eighteen members of which five are from the medical profession. These five are:

  1. Director General of Medical and Health Services, Ministry of Health and Social Welfare,
    Government of India.
  2. President of Medical Council of India.
  3. One person elected by the Central Council of the Indian Medical Association.
  4. One person elected by the Executive Committee of the Medical Council of India (from
 

amongst teachers in Medicine or Therapeutics).

  5. One pharmacologist elected by the Governing Body of the Indian Council of Medical
  Research.

-M.R. Shastri, Director (Retired), Drugs Control Administration, Gujarat
(Reproduced from: Bulletin of the Society for Rational Therapy, July 1991)

 


 

     
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