The small scale industries in the country are opposing the Union Health Ministry's proposed amendment, Drugs and Cosmetics (4th Amendment to Rules 2009), under which the pharma companies manufacturing products using narcotic and psychotropic substances have to file application in Form 24G and 25G instead of Form 24.

Terming the draft proposal, on which the ministry has invited objections and suggestions, as infirm and duplication with the existing rules/licences, the SME Pharma Industries Confederation (SPIC) has asked for a thorough review of the entire draft rules since the provisions that the government wanted to incorporate can be incorporated without disturbing the present fabric and structure in a major way.

Substantiating its claims, the SPIC said that it is provided in Rules 70, 71, 74 and rules 75, 76, 78 and other rules, forms of applications, licenses and conditions of licenses to manufacture schedule 'X' drugs which are a part of narcotic drugs and psychotropic substances provided in the said Act of 1985 and such drugs now shall form part of licenses granted on forms 25G and 28F if the proposed amendments are made rules, hence duplication.

Since there exists already licences on forms 25F and 28B as well as facility approved by SLAs and there is no demand for extra facility to manufacture drugs of proposed draft rules, the SPIC suggested to amend the list of drugs under Schedule 'X' to include narcotic drugs and psychotropic substances covered under the Act of 1985 which can be manufactured on licenses on forms 25F and 28B.

It also asked the government to amend the provisions under rule 74(m) and 78(n) to include the details desired to be provided in rules 72(b) and 77(b) of draft rules and provide for permissions to manufacture such drugs on loan license.

The infirmities found in the proposal include: No fee/facility is provided for manufacture of additional item on licenses on forms 25G. (Sub Rule (5) of rule 69 to be amended); No provision for providing duplicate copy of licenses granted on form 28F. (sub rule 4 of rule 75 to be amended); Rules 70, 71, 74, 75, 76 & 78 are to be suitably amended to prevent duplication since schedule 'X' drugs are a part of NDPS Act 1985; Heading of Rules 75 and 76 are to be changed to include Narcotic drugs and psychotropic substances; Provisions for grant of loan licenses to manufacture drugs in both categories are to be inserted. That shall involve amendments in rules 69A, 70A, 71B, 73A, 73AA, 74B 75A, 76A, 78A, 83A and 83AA. It is pertinent to mention that the proposed drugs are currently being manufactured on loan licenses on forms 25A &28A which are in vogue; Deletion of word 'Controlling Authority' from proposed changes in rules 72(b) and 77(b) being out of context since not mentioned in entire chapter. (VII) of Drug rules; Inclusion of words 'delete whichever is not applicable' below central licenses approving authority in licenses on forms 25G and 28F since not vested with powers; Proposed draft rules if made rules shall involve payment of another fee for those drugs which are already licensed and on which fee has been paid. Such payment is neither justifiable nor should be imposed; and Form 28F is found missing in the first para of Rule 76 which should be mentioned after 'Form 28D' just before Sub Rule (I) of Rule 76.