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CDSCO issues draft norms on good distribution practices for pharma products
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Arun Sreenivasan, New Delhi
September 29 , 2018
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The Central Drugs Standard Control Organisation (CDSCO) has released the draft guidelines on good distribution practices to regulate the supply chain and ensure the efficacy of pharmaceutical products sold in the country. The key tenets of the proposed storage and distribution practices were discussed at a recent meeting of the Drug Consultative Committee.
According to a circular issued by Drug Controller General of India Dr S Eswara Reddy this week, the norms, to be finalised after considering comments and suggestions from various stakeholders, will be incorporated in the Drugs and Cosmetics Rules of 1945 as a separate schedule to impart legal sanctity to it.
The rules are applicable to all parties involved in trade and distribution of drugs including bulk or finished product manufacturers, wholesalers, suppliers, government institutions, international procurement organisations, donor agencies, transport companies and health workers. Industry stakeholders can submit their comments on the proposed parameters till October 9.
The guidelines moot various measures to guarantee that medicines entering the distribution chain have proper documentation to permit traceability. Records of expiry dates and batch numbers should be part of the documentation to facilitate product recall. Moreover, procedures for procurement and release shall be in place to ensure that appropriate products are sourced only from approved suppliers and distributed by recognised entities. Inspection, auditing and certification of compliance with a quality system such as the ISO series or national guidelines by external bodies are recommended.
The norms are stringent about storage areas and transportation. The entire storage facility should be temperature mapped under representative conditions. Temperature mapping must show uniformity across the unit and it is recommended that monitors be located in areas that are most likely to show fluctuations.
Where special conditions are required during transportation that are different from or limit the given environmental conditions, for example, temperature and humidity, these should be provided by the manufacturer on the labels, monitored and recorded. If a deviation has occurred during transportation, it should be reported to the distributor and recipient of the affected products immediately.
The move to implement good supply chain management practices is part of the CDSCO’s efforts to ensure quality and traceability of medications. Not long ago, the national drug regulator announced a tracking mechanism and identified 300 top brands for the initiative on the basis of moving annual total data. The plan is to print a 14-digit number on their labels along with the manufacturers’ contact number, so that the consumer can check the genuineness of a drug. The tracking system, along with the newly proposed distribution practices, would go a long way in ensuring quality-assured medicines for consumers, say industry observers.
The initiatives assume significance, as according to national drug survey data, spurious drugs in the Indian market is only around 0.05 per cent while the share of not of standard quality (NSQ) drugs remains significant. According to a recent World Health Organisation (WHO) report, an estimated one in 10 medical products circulating in low- and middle-income countries like India is either substandard or falsified. According to the UN agency, these medicines not only fail to treat or prevent diseases but can also cause serious illness or even death.
Drug manufacturers and regulators blame lax supply chain management practices for this plight. “A drug manufactured at a plant in Uttarakhand travels by road or rail and reaches the other corner of the country in ordinary temperature. Storage facilities at lorry godowns are also poor. Unless we rectify these issues, nothing will change on the ground,” a former drug controller opined.
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