| 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. |
| Ayush is planning to enforce stringent licensing norms for the sector with a new licensing system at the state level. |
| A recent drug technical advisory board (DTAB) meeting has given clearance to an Ayush proposal to directstates 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. |
| According to industry sources, the decision could cause chaos in the industry, as currently more than 30,000 P&P drugs float in the market, constituting 90 per cent of the total ISM drug market. |
| The annual sales of these medicines are over Rs 5,500 crore, while the classical text-based drugs constitute only 10 per cent of the ayurveda, siddha and unani drug market. Further, a majority of the Rs 320 crore worth annual ISM drug exports belong to the P&P segment. |
| 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). |
| Many of the P&P medicines are available in the country for many decades. |
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