The union health ministry may give the government analysts a free hand to test the samples as per methods available to him in the standard books or journals, in case the manufacturer does not send the method of analysis for patent and proprietary medicines to the analysts for testing.
According to sources, the Drugs Consultative Committee (DCC), which held its 44th meeting on July 20, has recommended to ministry that in case manufacturer does not send the method of analysis for patent and proprietary medicines, the government analyst is free to test the sample as per method available to him in the standard books or journals.
The issue was raised in the DCC meeting by state drug authorities who informed the DCC that when a sample of patent and proprietary medicines is taken for test / analysis as per the provisions of the Drugs and Cosmetics (D&C) Act, 1940 and sent for analysis to the government analyst, more of the government laboratories demand test protocols and in some cases ask for reference standards.
Testing procedure and reference standard is to be provided by the manufacturer of the drug but it has been observed in some cases the manufacturer intentionally delay in supplying the test protocols / reference standard to avoid timely testing. The delay in testing ultimately benefits the manufacturer because after expiry the Apex laboratory will not accept the sample for retesting.
The report of state laboratory on form 13 can be challenged under section 24 of the D&C Act by the manufacturer, thus report of government analyst is not a conclusive report as per the Act, if it is challenged.
The DCC members argued in the meeting that provisions should be made that laboratory may call for test protocols / reference standard directly from the manufacturer or the concern inspector who has drawn the sample may ask for test protocols / reference standard from the manufacturer. The manufacturer may be bound to supply the required test protocols / reference standard within the stipulated period.
After deliberations, the DCC recommended that in case manufacturer does not send the method of analysis for patent and proprietary medicines, the government analyst is free to test the sample as per method available to him in the standard books or journals.