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
Image Source: pcimh.gov.in