CDSCO releases draft Guidelines to regulate and maintain quality, standards of pharmaceutical products, invites comments by October 16, 2018
The Central Drugs Standard Control Organization (“CDSCO”), in a Notice dated September 25, 2018, has published a draft copy of the Guidelines on Good Distribution Practices for Pharmaceutical Products (“Draft Guidelines”), with a view to maintain and control adequate quality standards of pharmaceutical products.
The proposed Guideline seeks to impact every chain of distribution dealing in Pharmaceutical Products operating across India.
On 30th July, 2018, an initiative was taken up by the Drugs Consultative Committee (“Committee”) to implement necessary provisions to add the Draft Guidelines as Schedule to the Drugs and Cosmetics Rules, 1945 with a view to penalize the offenders. The Committee keeping in mind of the same, took up an initiative to draft the Guidelines for the reasons as mentioned below.
Applicability of the Draft Guidelines:
- To all persons and outlets involved in any aspect of the storage and distribution of pharmaceutical products from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to a patient or his or her agent;
- All parties involved in trade and distribution of pharmaceutical, including the manufacturers of bulk, finished products, wholesalers, as well as others such as suppliers, distributors, Government institutions, international procurement organization, donor agencies and certifying bodies, logistics providers, traders, transport companies and forwarding agents and their employees as well as health workers.;
- Biological Products are also covered by the Draft Guidelines. However, for specific purpose, refer to the guidelines on Good Distribution Practices for Biological Products as published in CDSCO website.
Key highlights of the Draft Guidelines:
- Only authorized persons or entities who hold appropriate license will be entitled to import/export pharmaceutical products;
- There will be a regulatory mechanism at an organizational level for proper management of the chain of distribution;
- Every pharmaceutical product distributor will be required to establish and maintain a ‘Quality System’ as per the Draft Guideline. A Quality policy will be documented which would describe the overall intentions and requirements of distributors regarding quality standards,
- Recommendations have been made by the Committee for Inspection, auditing and certification of compliance by external bodies;
- Pharmaceutical products must be stored in a suitable, structured and well-designed storage area to ensure Good Storage Practices;
- Various aspects such as storage area temperature, environment, stock control and transportation have been pointed out in the Draft Guideline which needs to be complied by the entity dealing with pharmaceutical products;
- All records relating to each operation undertaken by the entity must be documented;
- Any sale and distribution of a suspected spurious pharmaceutical product will result in suspension which will further be escalated to the National Regulatory Authority;
- The entities are encouraged to undertake voluntary ‘Self-Inspection’. The self-monitoring system will be helpful for entities to ensure critical compliances and undertake preventive measures whenever necessary.