The Union health ministry will soon amend Schedule K of the Drugs and Cosmetics Rules, 1945 to make a provision for manufacture of 100 ml injectable to be manufactured under the licence for small volume parentarals for export by 100 per cent Export Oriented Units (EOUs).
According to sources, the 100 per cent EOUs have been facing problems because of the categorization of pack sizes 100ml injectables being considered as large volume parenterals which require them to have dedicated vial line and special permission, whereas internationally 100ml are considered as small volumes parenterals and injectable preparations of more than 100 ml are only considered as large volume parenterals.
The definition of large volume parenterals as provided under rule 76 provides that sterile solutions intended for parenteral administration with a volume of 100 ml or more (and shall include anti-coagulant solutions) in one container of the finished dosage form intended for single use. In view of this the sterile injectables of 100 ml are considered as large volume parenterals and licenced accordingly, and require licence in Form 28D or 28DA for its manufacture and sale. The small volume parenterals are, however, licensed by the state licensing authorities appointed by the state governments and licence for the purpose is granted in Form 28.
Earlier, Emcure Pharmaceuticals had some time back made a representation in this regard to Union commerce ministry. The commerce ministry took up the issue with the health ministry.
In order to boost exports and investment in India it is proposed to provide an exemption under Schedule K so that 100 per cent EOUs are permitted to manufacture 100 ml injectables as small volume parenterals under a licence in Form 28 granted by the State Licensing Authority (SLA) and are exempted from obtaining a licence in Form 28D or 28DA from the Central Licence Approving Authority provided that the drugs have been manufactured under a valid licence granted by the State Licensing Authorities, the commerce ministry said.
The health ministry asked the Drugs Technical Advisory Board (DTAB) to take a final call on this issue. The DTAB after deliberations agreed to the proposed amendment for export purpose only.