Sticking to his stand on linking patent status with marketing approval for drugs, the Drugs Controller General of India (DCGI) is preparing a guidance document to deny licences for copycat versions of medicines that have product patent in the country, even as discontent is growing in the industry over the move.

However, the DCGI would give marketing approvals to the drugs that have only process patents in the country while denying permission to the low cost Indian versions of product-patented drugs. The policy document, to be finalised in consultation with the industry, would be in place within a few months time to give concrete shape to the proposal, it is learnt.

In the run-up to the long-term goal of setting up a separate patent cell under the CDSCO to link the marketing approvals with the patents in lines of the systems existing in developed countries like the US and Canada, the DCGI is also planning to hire the services of a patent attorney to deal with the cases and for advices.

"We should look at it realistically. In countries like Canada, when application is made even on new molecules, it is sent to the patent department for clearance and they have own patent cell too. The mechanism abroad may not be fully applicable here, but we should have own system to honour the patents. We are planning to come out with a detailed guidance document in 5-6 months and will eventually set up own patent cell,'' DCGI Dr Surinder Singh told Pharmabiz.

However, he also made it clear that, the industry would be taken into confidence while preparing the policy document and it would be made public for suggestions from all the concerned parties.

It may be noted that after the DCGI announced the plans in this regard recently, creating ripples in the domestic industry which is thriving on the generic drugs. They termed it unwarranted while the multinational companies, who would be free of infringement fear by domestic players, have welcomed it wholeheartedly. On the other hand, such guidelines may avoid future cases like the ongoing court battle between Cipla and Swiss drug maker Roche over the cancer drug of Tarceva.