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Pharmacopoeia Commission for Indian Medicine

  • 06 Aug 2022
  • 6 min read

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.

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

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