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Drug regulator issues ‘Good Distribution Practices’ guidelines to ensure no substandard pharma products in market

Apr 19,2024

New Delhi: The country’s drug regulator has released draft guidelines on good distribution practices to curb the introduction of spurious, adulterated and sub-standard pharmaceutical products in the market. The draft guidance document issued by the Central Drugs Standard Control Organisation (CDSCO) is in line with the WHO Technical Report Series (TRS) on good storage and distribution practices for such products.

The guidelines will be applicable to all persons and outlets involved in any aspect of storage and distribution of pharmaceutical products from the premises of the manufacturer to the person dispensing the products to a patient or his or her agent.

“Not of standard quality and spurious products are a significant threat to public health and safety. Consequently, it is essential to protect the supply chain against the penetration of such products,” reads the draft ‘Guidelines on Good Distribution Practices for Pharmaceutical Products’.

It sets out steps to assist stakeholders in fulfilling their responsibilities in different stages within the supply chain to avoid the introduction of sub-standard products in market.

The draft has recommended the inclusion of self-inspections by a designated, competent person in an independent and detailed way in the ‘quality system’.

All pharmaceutical product distributors shall establish and maintain ‘quality system’, it said, adding a responsible person shall be appointed by the management for each distribution site with defined authority and responsibility to ensuring the ‘quality system’ is implemented and maintained.

The guidelines said deviations from the established procedures shall be documented and investigated. Appropriate corrective and preventive action (CAPA) shall be taken to correct deviations and prevent them, the guidelines said.

The document stated if a produced is needed to be recalled, it shall be segregated during transit and clearly labelled as recalled products. Where segregation in transit is not possible, such goods shall be securely packaged, clearly labelled and be accompanied by appropriate documentation.

All customers and competent authorities of all countries to which a given pharmaceutical product may have been distributed shall be informed promptly of any intention to recall the product, the draft document stated.

The returned products shall be destroyed in accordance with international, national and local requirements and with due consideration to protection of the environment unless it is certain that their quality is satisfactory, after they have been critically assessed in accordance with a written and authorised procedure, the document said.

Records for the dispatch of products should include a description of the products including name, dosage form and strength (if applicable), quantity, assigned batch number and expiry date, among other details.

It shall be ensured that records of dispatch contain enough information to enable traceability of the pharmaceutical product, the draft guidelines said.

Source: Pharma

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