Licences granted under D&C Rules forever

By: Parveen

Mumbai : Health ministry gets green signal to make amendment in Drugs & Cosmetics Rules, 1945. By making this amendments, the ministry wanted to further improve the quality of services provided by the drug regulatory authorities in the country. In its 74th meeting held on November 15, 2016, the DTAB agreed for the proposal that the manufacturing and sale licences once issued, shall remain valid forever, unless suspended or cancelled by the Licensing Authority subject to certain conditions. They include, such inspection for grant of licence shall be carried jointly by state and Centre involving relevant experts of respective area considering the category of the drug for GMP/GLP inspection; and such licensees shall be subjected to minimum of one annual inspection until unless justified otherwise on the basis of risk evaluation. The observations of the inspection report shall be shared with the licensee or proposed licensee immediately after the inspection and the report of observation of the inspection shall be made available to public on website of state or Centre. The recently published checklist by CDSCO on its website after for risk based GMP inspection may be used for inspection and publication of the report. State wise data about manufacturing units inspected and found satisfactory, should be maintained and uploaded on the website by state and central drug regulatory authorities involved in issue of such licences. Further it recommended that for one time grant of licence, the number of drug inspectors and other regulatory officials in respective areas at the state and central level shall commensurate with the number of manufacturing units in specific area / jurisdiction.To bring ease in doing business for making the “Make in India” concept a reality, the Drug Controller General of India (DCGI) Dr GN Singh has been in the process of revisiting several regulatory provisions under the Drugs & Cosmetics Rules (D&C Rules), 1945 to further improve the quality of services provided by the drug regulatory authorities of the states and the Centre. In fact, the DCGI has continuously been engaged in streamlining various activities under the Drugs & Cosmetics Act, 1940 and Rules, 1945 thereunder. The DCGI has already taken various important measures in recent months for streamlining the activities such as Import clearance through ICEGATE; Risk-based inspection of drug manufacturing facilities in the country based on check-list and evaluation tools developed for the purpose; Imparting training to the regulatory officials of states and Centre through various training modules to improve the quality of services provided by the regulators; and online submission and processing of several categories of applications through SUGAM portal.


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