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The government is contemplating introduction of guidelines to empower state drug inspectors and other regulators to be able to collect samples of medicines from the market on a regular basis.
There is no such organised mechanism for regulators. The latest proposal comes in the wake of a need to keep a check on quality as well as prices of medicines.
"There is no system for us to collect samples from the market. We, at times, do it on our own by seeking separate permission but that takes a lot of time," an official with one of the regulator's offices told Business Standard.
While recently, many such complaints were highlighted by regulators to the Department of Pharmaceuticals as well as the Ministry of Health and Family Welfare, the proposal to frame norms enabling regulators to regularly collect random samples from the retail level was mooted in one of the consultative meetings recently. "The proposal was discussed but a final call on the matter would require some more deliberations. It has to go through some of the expert panels before finally seeking an approval from the health ministry," another official said.
Usually drug samples are collected by state drug regulators, drugs inspectors from the office of the Drug Controller General of India as well as by the National Pharmaceutical Pricing Authority (NPPA). In the absence of any norms and proper budgeting, however, these regulators find it extremely difficult to monitor the market.
The recent developments in the domestic pharmaceutical market have highlighted the need to have a mechanism to keep a tab on retail practices. For instance, concerns raised by various international regulators on the quality of domestically manufactured medicines have triggered the need for regulators to regularly test quality of medicines available for Indian patients.
On the other hand, with the recent change in the pricing regime, state drug regulators as well as NPPA wants to collect sample regularly from the market to check violations.
The Indian pharmaceutical market is currently pegged at Rs 74,000 crore, growing at 10 per cent annually.
DRUG BOOST
* The latest proposal comes in the wake of a need to keep a check on quality and prices of medicines
* Proposal to frame norms will enable regulators to regularly collect random samples from retail level
* Proposal has to go through some of the expert panels before finally seeking an approval from the health ministry
* The new guidelines would meet the needs of the domestic pharmaceutical market by keeping a tab on retail practices and testing samples regularly
