The Health Ministry, which is planning a couple of changes in the conditions for licences, will hold wider consultations before taking a decision on amending the laws under Rule 64 of the Drugs and Cosmetics (D&C) Rules to make only the registered pharmacist as the competent person to take up wholesaling of drugs as per the norms in Form 20B, 20G and 21B.

The proposal, demanded by the pharmacist bodies for a long time and also came up before the recent meeting of the Drugs Consultative Committee (DCC), was that the educational qualification to act as a Competent Person must be fixed as a Registered Pharmacist only. Other qualification/experience may not be considered. However, it was decided that the government should hold wider consultations before finalizing such changes.

However, some other changes are being planned in the conditions of licence/loan licence to manufacture/ repack for sale of drugs/cosmetics/to operate blood bank for processing of whole human blood and/or preparation for sale or distribution of its components or approval for carrying out tests on drugs/cosmetics and raw materials used in their manufacture on behalf of licensees for manufacture of drugs/cosmetics.

These will be effected through Form 25, 25A, 25B, 25C, 32, 32A and condition of licences/approval in Form 25F, 28, 28A, 28B, 28C, 28D, and 37. Any change in the competent technical staff named in the licence/appointment of additional technical staff shall be reported to the Licensing Authority within seven days of such change/appointment, according to the proposed change.

In the case of Form 37, it would be amended to make sure that any change in the analytical staff or in the person-in-charge of the testing/appointment of additional analytical staff shall be reported to the Approving Authority within seven days of such change/appointment.

Another change, with regard to the Form 20-B, 21-B, 20-G will be that a time of one month would be fixed for reporting of change in Competent Person for wholesalers and the conditions which are reflected on the body of licences. “The licensee shall report to the Licensing Authority any change in the Competent Person within one month of such change,” says the proposed change.