|
In an effort to address the concerns raised from time to time regarding the quality, safety and efficacy of the drugs and uniform implementation of the provisions of the regulations, the central drug regulator has been contemplating a comprehensive approach through implementation of a set of measures including uniform documentation, uniformity in enforcement and uniform market surveillance.
This includes uniform implementation of document/dossier based approval for licensing of drugs across the country, uniformity in enforcement through the already initiated risk-based inspection of drug manufacturing sites, uniform implementation of market surveillance for quality monitoring in the supply chain, among others.
In the 61st meeting of the Drugs Consultative Committee (DCC) held in June, 2023 deliberated these aspects and opined that the uniform implementation of document based licensing will be able to address many issues relating the quality of drugs manufactured in the country.
It was also deliberated that a specified checklist / format may be developed which can be adopted uniformly across the country. The checklist presently being used for approval of subsequent new drugs in CDSCO may be used after appropriate modification required as per the Drugs rules, 1945, said the DCC in its minutes which was published by the Central Drugs standard Control Organisation (CDSCO) lately.
The committee after detailed deliberation recommended that the dossier/document based licensing of the drugs should be implemented uniformly across the country and the checklist for submission of documents by the applicant may be prepared based on the checklist of subsequent new drugs followed at CDSCO.
The committee also recommended that a letter should be issued by the Drugs Controller General (India) advising the State Licensing Authorities to implement the documents based licensing uniformly across the country.
While presently about one lakh drugs samples are tested, in case of samples tested and declared as not of standard quality, spurious/adulterated drugs, due to lack of comprehensive common database of details of the licensees, the products, inspections and enforcement activities, etc. and proper coordination, information sharing amongst various States/UT, there had been major challenges in carrying out investigations and launching of prosecutions, observed the Committee.
After detailed deliberation, it recommended that uniform implementation in drawing of samples of drugs/cosmetics/medical devices through a guidance document will enhance the market surveillance for better monitoring of the quality of the drugs. Therefore, the committee recommended developing a guidance document in consultation with the stakeholders.
It may be noted that the regulator has already started joint risk-based inspections of drug manufacturing sites across the States and Union Territories, with the DCC observing that non-uniformity in the interpretation of the provisions of the law and their implementation, lack of adequate infrastructure and varying level of the competence of the regulatory officials have resulted in varying level of performance.
The Committee deliberated that in order to optimise the allocation of resources ensuring better quality products, compliance to the good manufacturing practices (GMP) should be uniformly checked through a risk-based approach to inspections. The facilities that need to be inspected based on history of inspection, risk associated with the product, findings of past inspections, NSQ drugs etc.
The discussions were in the backdrop of various reports and perspectives which raised concerns about the quality and efficacy of the drugs manufactured in the country and sold both in India and in the export markets.
|