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Ministry notifies revised rules to ensure quality of medicines

Ministry notifies revised rules to ensure quality of medicines
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Ministry notifies revised rules to ensure quality of medicines

  • The Ministry of Health and Family Welfare in India recently introduced revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945.

Objective of Revision

  • The revision of Schedule M aims to strengthen pharmaceutical manufacturing standards in India.
  • This is in response to global scrutiny and concerns about sub-standard medicines exported from India.
  • The focus is on ensuring the manufacture of safe, effective, and high-quality drugs compliant with international quality standards.
  • It aims to align Good Manufacturing Practices (GMP) recommendations with global standards, particularly those of the WHO.

Global Scrutiny

  • India faced global scrutiny after the WHO issued an alert regarding the contamination of cough syrups with diethylene glycol and ethylene glycol, considered toxic and potentially fatal.
  • QP Pharmachem Ltd, a Punjab-based company, had its manufacturing licence suspended after its cough syrup was linked to child deaths in Gambia and Uzbekistan.

Revised Categories and Sections

  • Five new categories of drugs have been introduced, including pharmaceutical products containing hazardous substances.
    • These include sex hormones, steroids, cytotoxic substances, biological products, and radiopharmaceuticals.
  • Additional sections include
    • Introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR)
    • Qualification and validation of equipment
    • Computerized storage system for drug products
  • The manufacturer is required to assume responsibility for the quality of pharmaceutical products.
    • They must ensure they are fit for use, comply with licence requirements, and do not pose risks to patients.

Quality Assurance Measures

  • Companies must market a finished product only after obtaining satisfactory results from tests of ingredients.
  • Adequate samples of intermediate and final products must be retained for repeated testing or verification of a batch.

Implementation Timeline

  • Small manufacturers with an annual turnover of less than Rs 250 crore will have 12 months to implement the revised rules.
  • Large manufacturers with an annual turnover exceeding Rs 250 crore will be given six months for implementation.

Prelims Takeaway

  • Drugs and Cosmetics Rules, 1945
  • Good Manufacturing Practices (GMP)

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