New drug policy may not be ready by Nov end as DOP needs revised list of NLEM
Despite the assurance by the Government before the Supreme Court on the finalization of the new drug policy by the end of November, it is likely to be delayed further as the Department of Pharmaceuticals (DoP) needs to get revised the National List of Essential Medicines (NLEM) to be notified under the Drugs Price Control Order (DPCO).
The Department has already prepared the Cabinet note based on the recommendations of the Group of Ministers (GoM) which suggested weighted average price as mechanism to control the prices of essential drugs. The Cabinet note, it is learnt, was circulated among the ministries concerned and got positive responses from the most.
However, the note has to be redrafted now as per the ruling of Supreme Court which directed the Government not to change the existing cost-based mechanism, which the GoM wanted to replace with WAP (weighted average Price).
“The process is on. But it is pretty long process as we have to get the NLEM list now revised and put them under the DPCO. It can take time,” a senior official from the DoP said, hinting that Government will seek more time from the court by submitting the views of the Cabinet which is expected to go through the matter next month.
The NLEM has to be revised by the Health Ministry first. It was after seven years gap, that the Ministry revised the list and published the NLEM 2011. Earlier, it was revised in 1996 and 2003. An expert committee was set up to revise the list after much deliberations and it came out last year.
Significantly, the government move that prolonged over a decade in finalizing the drug policy also came to a naught now. After revising the draft several times since 2002, the GoM had finally decided to go for average weighted price as mechanism to fix prices. However, with the SC turning it down, now the Government has to adopt the DPCO route which the public health organizations had been pressing for long.
DPCO is a government order under Section 3 of the Essential Commodities Act, 1955, to control the prices of drugs. In the 70s, there were 347 drugs listed as essential life-saving medicines and were under the DPCO. The government admitted that more than 300 drugs were under DPCO in the early 1980s, which was subsequently reduced to 140 in 1987. At present, prices of only 74 bulk drugs and formulations are under the price control regime. Once a medicine is brought under DPCO, it cannot be sold at a price higher than that fixed by the government.