Govt orders new drug-making standards after overseas deaths

News Excerpt:

After several overseas deaths allegedly linked to India-made drugs, the Union Health Ministry has notified its Good Manufacturing Practices (GMP) that aim to ensure the quality of drugs made in the country, directing pharmaceutical companies to implement them within a year.

About the new Good Manufacturing Practices (GMP):

  • It focuses on quality control measures, allows mechanisms for digitally maintaining records that cannot be tampered with, and puts in place a system to recall drugs if necessary.
  • Large companies with more than Rs 250 crore turnover must implement the guidelines within the next six months
    • Small and medium manufacturers with a turnover of less than Rs 250 crore will get a year.
  • The revised GMP guidelines focus on quality control, proper documentation, and IT backing to maintain the quality of medicines produced. 
  • It also creates a recall mechanism for drug manufacturing companies.
  • The new guidelines require companies to conduct regular quality reviews of all their products, verify the quality and processes' consistency, thoroughly investigate any deviation or suspected defect, and implement preventive actions. 
  • It also says that all changes that may affect the production or quality of the product must be validated first.
  • The guidelines also state that companies should have GMP-related computerized systems, which ensure that there is no tampering of data related to the processes
  • In addition, the new schedule M also lists the requirements for additional types of products, including biological products, agents with radioactive ingredients, or plant-derived products.
  • Companies must market a finished product only after getting "satisfactory results" on tests of the ingredients and retain a sufficient quantity of the samples of intermediate and final products to allow repeated testing or verification of a batch.

Challenges regarding drug manufacturing in India:

  • A risk-based assessment of 254 manufacturing units and 112 public testing labs by the apex drug regulator found poor documentation and a wide range of deficiencies  in - 
    • Process and analytical validations, 
    • Self-assessment, 
    • Failure investigation, 
    • Internal quality review, 
    • Testing of incoming raw material, 
    • Infrastructure to avoid cross-contamination, 
    • Professionally qualified employees,
    • Faulty design of manufacturing and testing areas.
  • Last year, Indian syrups and eye drops were allegedly found to be contaminated.
    • The WHO and other health authorities have linked Indian cough syrups to the deaths of at least 141 children in Gambia, Uzbekistan, and Cameroon.

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