The Union Ministry of Health and Family Welfare has notified Drugs & Cosmetics (4th Amendment), Rules, 2017 dated February 2, 2017 vide G.S.R. 103(E) specifying the norms for import of drugs by charitable hospitals which is free of cost and fixing the time limit for testing of drugs as 60 days. So far there was no provision for the same. Now these new rules are enforced with immediate effect.

The notification dated 2nd February, 2, 2017 vide G.S.R. 103(E) to amend the Drugs and Cosmetics Rules, 1945 mentions that draft of certain rules was published as required by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 vide notification no. GSR 667 (E) dated July 5, 2016 inviting objections and suggestions from persons likely to be affected. The central government after consultation with the Drugs Technical Advisory Board has now issued the notification.

The notification also mentions in the ‘Note’ portion as “The principal rules were published in the official gazette vide notification number F. 28-10 / 45-H (1), dated the December 21, 1945 and last amended vide notification number G.S.R. 76(E) dated January 31, 2017.”

According to the notification, in the Drugs and Cosmetics Rules, 1945 after rule 36, a new Rule 36-A is being inserted which will refer to the permission of import of drugs by charitable hospital provided such drugs are given or administered to their patient free of cost.

It also mentions that “the drugs shall not be prohibited for import and permitted to be marketed in the country with residual shelf-life of one year or more”.

Further sub rule 1 of Rule 45 has been amended to incorporate the maximum time limit of 60 days to furnish the test report of the results of test or analysis of drugs and cosmetics after receipt of the sample and also the Government Analyst has been permitted to seek the extension of time from the Government giving specific reasons for delay in such testing analysis.

The duration of license to manufacture drugs for purposes of examination, test or analysis has been enhanced to three years from present one year by amending relevant rule 91 and concerned Form 11 and 29. The provisions of standards for veterinary drugs vide rule 124A also has been deleted.

Food Safety and Standards Act, 2006 under Section 46 stipulates the food analyst a time frame of 14 days to submit report from the date of receipt of any sample for analysis. Such a such a time frame was not provided so far under Drugs and Cosmetics Rules for testing of drugs and cosmetics.

In his capacity as National Adviser (Drugs Control) to MoHFW, GOI & CDSCO, Dr. BR Jagashetty had requested for a time frame for 30-45 days since 60 days is seen as a longer time frame. In any case, the move by the government to mandate a time limit for testing of drugs as 60 days has brought in some system to regulate the main purpose of the Drugs and Cosmetics Act, 1940 with respect to the quality of drugs and cosmetics in the market. In the absence of such a provision under D&C Act and rules the Government Analysts were not bound to give reports in any stipulated time thereby defeating the purpose of drawing the samples for test and analysis by concerned,” pointed out Dr. Jagashetty.