Pharma industry requests government to delay release of new NLEM list

Considering the pandemic situation across the country and difficulties in operating businesses in present conditions, the pharma industry has requested government authorities to delay the release of National Essential List of Medicines (NLEM) 2020 by one year.

Yesterday, a virtual meeting of the National Committee on Medicines (NCM) was held. It was attended by industry stakeholders and key government authorities, mainly from the CDSCO, DoP, ICMR, NPPA and DGHS etc.

During the meeting, industry stakeholders also presented issues related to the NLEM list 2015 and suggested course corrective measures in the upcoming NLEM list such as:

1) Essentiality should be the sole criteria for the upcoming NLEM list, and it should be assessed particularly from the Indian context
2) Specific medicine strengths and dosages should be mentioned in the list
3) Only one drug should be incorporated in each category
4) Patented drug should be excluded from the list
5) Only DCGI-approved drugs should be part of the upcoming NLEM list
6) Sustained-release drugs should be specifically mentioned in the list
7) Some high priced drugs like cancer medicines which were already under trade margin rationalisation should not be further included in the upcoming NLEM list

The key agenda of the meeting was to discuss and mandate the prices of drugs from therapeutic areas of cancer, anti-diabetes and thyroid but yesterday’s deliberations were directed more on the practical problems faced by the industry pertaining to the current NLEM.

Dr Amit Rangnekar, Chairman, Pricing Committee, IDMA said, “The new national list of essential medicines is very significant, as it would form the basis for inclusion/exclusion of drugs under DPCO. Due to the COVID situation, the IDMA has requested for postponement of the new NLEM to the next year as there are major operational issues faced by the industry currently. IDMA has recommended that essentiality should be the sole criteria for inclusion of medicines in the new NLEM, and they should be as per strengths and dosages recommended by doctors in India. IDMA has also suggested that only DCGI approved formulations, with sufficient market data available, should be included in the new NLEM.”

“Although the industry appealed to the government authorities to delay releasing NLEM 2020 for some time, the government has not given any formal indications about accepting their request,” informed a senior official involved in the development.