Context: The Union Cabinet has given its approval to re-establish Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) as Subordinate Office under Ministry of AYUSH. 

More on News:

  • This would involve merging Pharmacopoeia Laboratory for Indian Medicine (PLIM) and Homoeopathic Pharmacopoeia Laboratory (HPL)- the two central laboratories into the Commission.

About Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) 

  • It is an autonomous organization under the Ministry of AYUSH, Govt. of India. 
  • It has a primary mandate of publishing Pharmacopoeias and Formularies for drugs/formulations used in Ayurveda, Siddha, Unani (ASU) and Homoeopathy (ASU&H) systems of Medicine.
  • It aims to promote and preserve the well-being of humans and animals in India, by bringing out official standards for quality of drugs included in Ayurveda, Siddha, Unani & Homoeopathy systems of Medicine used by AYUSH professionals and consumers. 
  • The Commission serves as an umbrella organization for - 
    • Ayurvedic Pharmacopoeia Committee (APC), 
    • Siddha Pharmacopoeia Committee (SPC), 
    • Unani Pharmacopoeia Committee (UPC) and 
    • Homoeopathic Pharmacopeia Committee (HPC). 
  • Pharmacopoeial Laboratory for Indian Medicine (PLIM) and Homoeopathic Pharmacopoeia Laboratory (HPL) are its supporting structures.  
  • The Commission was initially established as the Pharmacopoeia Commission for Indian Medicine (PCIM) in the year 2010. 
  • However, in pursuance to the decision of the Central Government (in 2014), Homoeopathy was incorporated and the Commission was renamed as Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H).

Significance of Merger:

  • The merger is aimed at optimizing the use of infrastructural facilities, technical manpower and financial resources of the three organizations.
  • It will facilitate focused and cohesive development of standards of AYUSH drugs and publication of pharmacopoeias and formularies. 
  • It is also intended to accord legal status to the merged structure of PCIM&H and its laboratory by virtue of making necessary amendments and enabling provisions in the Drugs & Cosmetics Rules, 1945. 
  • Post-merger it will have adequate administrative structure under the Ministry
    • To strive for augmenting the capacity and outcomes of pharmacopoeial work and 
    • To prevent duplication and overlapping of drug standardization work.

Drug and Cosmetics Rules, 1945:

  • These are the set of rules under The Drugs and Cosmetics Act, 1940. 
  • It contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.
  • The Rule 67 details the conditions of licenses. 
  • The Rule 97 contains the labeling regulations.
  • The notable Schedules are:
  • Schedule G: Most of these drugs are hormonal preparations.
    • The drug label must display the text "Caution: It is dangerous to take this preparation except under medical supervision" prominently. 
    • Examples of substances under this schedule: Testolactone, Hydroxyurea, Carbutamide, Primidone etc.
  • Schedule H: The drug label must display the texts "Rx" and "Schedule H drug Warning : To be sold by retail on the prescription of a Registered Medical practitioner only" prominently. 
    • It can only be supplied to licensed parties. 
    • It cannot be sold without a prescription and only the amount specified in the prescription should be sold. 
    • The time and date of prescription must be noted. 
    • Examples: androgenic, anabolic, oestrogenic and progestational substances; Alprazolam (Xanax), Hepatitis B vaccine, Ibuprofen, Vasopressin etc.
    • If a Schedule H drug also comes under the purview of Narcotic Drugs and Psychotropic Substances Act, 1985, it must carry the texts "NRx" and "Schedule H drug. Warning
  • Schedule X: All the regulations of Schedule H apply. 
    • The retailer must keep a copy of the prescription for two years. 
    • The drugs must be kept under lock and key. Examples: Secobarbital, Glutethimide etc.
  • Schedule J: Contains a list of various diseases and conditions that cannot be treated under any drug currently in market. 
    • No drug may legally claim to treat these diseases


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