Pharmacopoeia Commission for Indian Medicine

• 06 Aug 2022

For Prelims: Ministry of AYUSH, AYUSH Drugs, Drug Regulations

For Mains: Significance of PCIM&H, Government’s Intervention

Why in News?

The Government of India has established the Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) as a subordinate office under the Ministry of Ayush.

• Government has merged the Pharmacopoeia Commission of Indian Medicine & Homoeopathy (PCIM&H) and the two central laboratories namely:
  • Pharmacopoeia Laboratory for Indian Medicine (PLIM) and
  • Homoeopathic Pharmacopoeia Laboratory (HPL).

What do we need to know about the Commission?

• About:
  • PCIM&H is an autonomous body under the aegis of Ministry of Ayush, established since 2010.
  • Pharmacopoeia is an officially recognized book of standards as per the Drugs and Cosmetics Act, 1940 and Rules 1945 thereunder.
    • As per the Second Schedule of the Drugs and Cosmetics Act, it is designated as the official book of standards for drugs imported and/or manufactured for sale, stock or exhibition for sale or distribution in India.
    • It specifies the standards of drugs manufactured and marketed in India in terms of their identity, purity and strength.
• Functions:
  • The Commission is engaged in development of Pharmacopoial Standards for Ayurvedic, Unani, Siddha & Homeopathic drugs.
  • PCIM&H is also acting as Central Drug Testing cum Appellate Laboratory for Indian systems of Medicine & Homoeopathy.
• Benefits of Merger with PLIM & HPL:
  • Optimum use of infrastructural facilities, technical manpower and financial resources of the three organizations for enhancing their standardised outcomes.
  • Focused and cohesive development of standards of AYUSH drugs and publication of pharmacopoeias and formularies.
  • The merger intends to accord legal status to the merged structure of PCIM&H and its laboratory by making the necessary amendments and enabling provisions in the Drugs and Cosmetics Rules, 1945.
    • Consultations have been done with the Director General Health Services, Drugs Controller General and the Ayurveda, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB).

What is Ayurveda, Siddha and Unani Drugs Technical Advisory Board?

• ASUDTAB is a statutory body under the provisions of Drugs and Cosmetics Act, 1940.
• It advises the central and state governments in regulatory matters of Accelerated Shelf Life Testing (ASLT) drugs.
  • ASLT is an indirect method of measuring and estimating the stability of a product by storing the product under controlled conditions that increase the rate of degradation occurring in the product under normal storage conditions.

How is the Government Supporting AYUSH Products/Drugs?

• Drugs and Cosmetics Act 1940:
  • Enforcement of the legal provisions pertaining to Quality Control and issuance of drug license of Ayurveda, Siddha, Unani, is vested with the State drug Controllers appointed by the concerned State.
  • It provides the regulatory guidelines for issuing licenses to manufacture Ayurvedic, Siddha, Unani medicines.
  • It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units & medicines including proof of safety & effectiveness, compliance with the Good Manufacturing Practices (GMP).
• Certifications of AYUSH products:
  • For facilitating exports, Ministry of Ayush encourages following certifications of AYUSH products as per details below:
    • Certification of Pharmaceutical Products (CoPP) as per WHO Guidelines for herbal products.
    • Quality Certifications Scheme implemented by the Quality Council of India (QCI) for grant of AYUSH Premium mark to Ayurvedic, Siddha and Unani products on the basis of third-party evaluation of quality in accordance with the status of compliance to international standards.
• AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY):
  • The Ministry of Ayush has implemented the Central Sector Scheme of AOGUSY.
  • Objectives:
    • To enhance India's manufacturing capabilities and exports of traditional medicines and health promotion products under the initiative of Atmanirbhar Bharat.
    • To facilitate adequate infrastructural & technological upgradation and institutional activities in public and private sector for standardization, quality manufacturing and analytical testing of Ayush drugs & materials.
    • To strengthen regulatory frameworks at Central and State level for effective quality control, safety monitoring and surveillance of misleading advertisements of Ayush drugs.
    • To encourage building up synergies, collaborations and convergent approaches for promoting standards and quality of Ayush drugs & materials.

UPSC Civil Services Examination, Previous Year Questions (PYQs)

Q. How is the Government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies? (2019)

Source: PIB