Health ministry plans to revise licensing fee structure for homoeopathic drugs

The Union health ministry is planning to increase the fees for licenses of homoeopathic drugs as there is some ambiguity in the existing rules, especially in the case of granting approvals to additional items by the license holders. “Rule 85-B(5) provides for fee of Rs.50 for approval of additional item by license holders . As per Rules 85-B(2), there is no limit for the items to be approved at the time of grant of license. Thus an applicant can have as many items as he wants by depositing just Rs.250 while a license holder is required to pay Rs.50.per item as additional items. It appears that, there is some ambiguity in the Rules, which needs to be looked into,” sources said. Taking into account of this aspect, it has been decided that an expert panel would consider reviewing the matter and suggest increase in the fees, along with revision of fees in allopathic drugs which is under process now. The matter came up before the Drug Consultative Committee (DCC) also and got its approval for revision of fees. Already a panel had been constituted to look into the fee structure of contract manufacturing licenses after the issue was raised by many States. DCC had constituted a sub-committee consisting of Drugs Controllers of Odisha, Uttar Pradesh and Maharashtra and with Dr. V G Somani, deputy drugs controller, CDSCO, HQ as convener to examine the matter in detail and give recommendations for changes, if any, under the Drugs and Cosmetics Rules, 1945. This committee is expected to go into the possible revision of license fees for homoeopathic medicines also. The panel has been asked to submit the recommendations by next month, sources revealed. Source:Pharmabiz