Revised Good Manufacturing Practices Standards

• 08 Aug 2023

For Prelims: Good Manufacturing Practices, Pharmaceutical quality system, Pharmaceutical Companies, Drugs Manufacturing Standards, Deaths of Children in the Gambia.

For Mains: Revised Good Manufacturing Practices Standards.

Source: IE

Why in News?

Recently, the government of India has directed all pharmaceutical companies to implement the Revised Good Manufacturing Practices (GMP), bringing their processes at par with Global Standards.

• Larger companies with a turnover of over Rs 250 crore have been asked to implement the changes within six months, while medium and small-scale enterprises with turnover of less than Rs 250 crore have been asked to do so within a year.

What are Good Manufacturing Practices (GMP)?

• About:
  • GMP is a system for ensuring that products are consistently produced and controlled according to quality standards.
  • It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
• The Main Risks:
  • Unexpected contamination of products
  • Causing damage to health or even death
  • Incorrect labels on containers, which could mean that patients receive the wrong medicine
  • Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.
• WHO (World Health Organization) has established detailed guidelines for GMP. Many countries have formulated their own requirements for GMP based on WHO GMP.
• Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.
• The GMP system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945, and the last amendment was done in June 2005. WHO-GMP standards are now part of the revised Schedule M.

What are the Major Changes in Revised GMP Guidelines?

• Pharmaceutical Quality System and Risk Management:
  • The new guidelines introduce a pharmaceutical quality system, which emphasizes the establishment of a comprehensive quality management system throughout the manufacturing process.
  • Companies are now required to implement quality risk management practices to identify potential risks to the quality of their products and take appropriate preventive measures, also regular quality reviews of all products are mandated to ensure consistency in quality and processes.
• Stability Studies:
  • Companies are now required to conduct stability studies based on climate conditions. This involves maintaining drugs in stability chambers at specified temperatures and humidity levels to assess their stability over time. Additionally, accelerated stability tests may be conducted to assess the product's stability under accelerated conditions.
• GMP-Related Computerized Systems:
  • The new guidelines emphasize the use of computerized systems to manage GMP-related processes.
  • These systems are designed to prevent data tampering, unauthorized access, and omission of data. They also automatically record all steps and checks to ensure adherence to processes without any tampering.
• Investigational Products for Clinical Trials:
  • The new schedule M also lists out the requirements for additional types of products, including biological products, agents with radioactive ingredients, or plant-derived products.
  • The new guidelines lay out requirements for investigational products being manufactured for clinical trials. This ensures that the products used in clinical trials meet the necessary quality and safety standards.

What is the Need for Revised GMP Guidelines?

• Alignment with Global Standards:
  • Implementation of the new norms will bring the Indian industry on par with global standards.
• Incidents of Contamination:
  • There have been a string of incidents where other countries have reported alleged contamination in India-manufactured syrups, eye-drops, and eye ointments.
  • The deaths of 70 children in the Gambia, 18 children in Uzbekistan, three persons in the United States, and six deaths in Cameroon have been linked to these products.
• Deficiencies in Current Practices:
  • Risk-based inspection found numerous deficiencies in 162 manufacturing units in India.
    • Deficiencies include inadequate testing of raw materials, lack of product quality review, infrastructure issues, and missing qualified professionals.
  • There are only 2,000 of the 10,500 drug manufacturing units in India at present that meet global standards, being WHO-GMP certified.
  • The improved standards will ensure that pharmaceutical companies follow standard processes, quality control measures, and do not cut corners, improving the quality of medicines available in India as well as sold in the global market.
• Confidence to Regulators from Other Countries:
  • Instituting the same quality across the industry will give confidence to regulators from other countries.
  • In addition, it will improve the quality of drugs in the domestic markets. Most of the 8,500 manufacturing units that are not WHO-GMP certified supply medicine within India.

Way Forward

• India's move to implement revised GMP guidelines signifies a significant step toward achieving global quality standards in the pharmaceutical industry.
• The revised standards aim to enhance quality control measures, proper documentation, and IT support, thus ensuring the production of high-quality medicines in India and for the global market.