Drug Regulation Innovation

Govt to weed out "irrational" patent & proprietary traditional drugs


There was this piece by P B Jayakumar in BS about proposed new licensing norms in the Indian Systems of Medicine industry. I reproduce it in parts below:

The Department of Ayush, which regulates the estimated Rs 6,000-crore ayurveda, siddha and unani Indian Systems of Medicine (ISM), has initiated new licensing norms to weed out irrational patent and proprietary (P&P) medicines, which are innovated products not mentioned in classical texts of the ISM.”

The department’s move comes close on the heels of the Drug Controller General of India’s attempts to weed out ‘irrational’ pharmaceutical formulations or innovated fixed-dose combinations (FDCs) of known chemical compounds combined not in accordance with pharmacopoeia standards.

A recent drug technical advisory board (DTAB) meeting has given clearance to an Ayush proposal to direct states to set up a panel of experts, including a physician and a drug control official, to replace the existing system of an ISM licensing authority, which licenses drugs in accordance to his judgement, said sources with the Ayush department.

It will have interesting implications on the Rs 6,000-crore ISM drug market, considering that the 30,000 P&P drugs constitute 90 per cent of the total market. (In contrast, the classical text-based drugs have only about 10 per cent share.)

One grouse seems to be the apparent conflation of traditional drugs with other pharmaceutical formulations. The report quotes:

The industry fears the move will cause inordinate delay in getting licenses and deny introduction of innovated time-tested ISM drug products, besides causing withdrawal of some of the P&P drugs in the market.

“Ayurveda products are based on trials and experience of the physicians practicing this system, which has a history of many centuries. It is unfair to view our drugs with the same yardsticks applied to chemical formulations, which have proven side effects in many cases,” said Ranjit Puranic, the general secretary of the Ayurvedic Drug Manufacturers Association (ADMA).

I don’t quite agree with Mr Puranic. I don’t think it disincentivizes innovation in the ISM sector. Neither do I believe that it is unfair to use yardsticks similar to pharmaceutical chemical formulations. At the very least, this will serve to establish the robustness of the traditional Indian medical system, and affirm its efficacy and usefulness in comparison with other, non-traditional systems.

I think overall it is a positive move by the Department. I don’t have details of the existing system of licensing, but if this report is anything to go by, there appears to be immense license (sic) given to the licensing authorities themselves in granting approval to ISM drugs. This new regulation would systematize the procedure, and lessen the chances of corruption or other forms of misconduct in the process.

As ever, we are keen to know what SpicyIP readers think about this regulation.

Leave a Reply

Your email address will not be published.