Context: The Ministry of Health and Family Welfare notified revised rules under Schedule M of the Drugs and Cosmetics Act, 1945
Reasons for revised rules
- The country felt intense global scrutiny after the World Health Organization (WHO) issued an alert about cough syrups being contaminated with diethylene glycol and ethylene glycol which is fatal to humans.
- Cases of alleged contamination have also been reported from cough syrups made in India.
- Observations from ongoing risk-based inspections further emphasise the need for a relook at current Good Manufacturing Practices (GMP) regulations and quality management systems being followed by pharmaceutical manufacturers.
- To bring our GMP recommendations on a par with global standards WHO’s Good Manufacturing Practices.
- The amended Schedule M will help in greater acceptance and trust in exports of India’s pharmaceutical products across the globe.
Schedule M of the Drugs and Cosmetics Act
- Schedule M of the Drugs and Cosmetics Act, 1945 provides Good Manufacturing Practices for pharmaceutical products.
- The standards laid down by Schedule M of the Drugs and Cosmetics Act, 1945 have to be mandatorily followed by pharmaceutical manufacturers.
- Under the amendment, the words ‘Good Manufacturing Practices’ has been replaced by ‘Good Manufacturing Practices and Requirements of Premises, Plant & Equipment for Pharmaceutical Products’.
- These amendments to the Schedule M of Drugs and Cosmetics Act, 1945 will bring ‘Good Manufacturing Practices’ being followed in India at par with the global standards, especially the ‘Good Manufacturing Practices’ laid down by the World Health Organisation.
Revised rules
- The latest revision includes five new categories of drugs —
- pharmaceutical products containing hazardous substances such as sex hormones, steroids (anabolic and androgenic),
- Cytotoxic substances.
- Biological products and
- Radiopharmaceuticals.
- It also has additional sections including —
- Introduction of a pharmaceutical quality system (PQS),
- Quality risk management (QRM),
- Product quality review (PQR),
- Qualification and validation of equipment.
- computerised storage system for all drug products.
According to the new notification, the manufacturer must assume:
- Responsibility for the quality of pharmaceutical products
- To ensure that they are fit for use,
- Comply with the requirements of the license,
- Do not place patients at risk due to inadequate safety, quality, or efficacy.
- The revised rules are set to be implemented on the basis of company turnovers.
- Medium and small manufacturers with an annual turnover of less than Rs 250 crore have to implement the revised rules within 12 months from the date of publication,
- Large manufacturers with an annual turnover of over Rs 250 crore will be given six months.
Significance
- The revision aims to ensure that the pharma sector recommits to the manufacture of safe, effective, and high-quality drugs in compliance with international quality standards, thus benefiting both patients and industry.
- This is a response to the backlash India has been receiving over reports of sub-standard medicine being exported from India.
WHO Good Manufacturing Practices
- Good Manufacturing Practices (GMP) are also referred to as current Good Manufacturing Practices (cGMP) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by product specifications.
- WHO Good Manufacturing Practices is an integral basis of the WHO Certification Scheme of pharmaceutical products moving in international commerce and prequalification of vaccines for procurement by UN agencies.