Lok Sabha Question No. 2658 (UNSTARRED), answered on 2017-08-01
Subject: Essential Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: KAUSHAL KISHORE

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

## LOK SABHA

## UNSTARRED QUESTION No. 2658

## TO BE ANSWERED ON THE 1 st  August, 2017

## Essential Medicines

†2658. SHRI KAUSHAL KISHORE:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether 108 of the total medicines produced in India are useful for the treatment  of  many  serious  diseases  including  cancer,  diabetes,  high  blood pressure  and  heart  disease  have  been  delisted  from  the  list  of  essential medicines by the National Pharmaceutical Pricing Authority;
- (b) if so, the details thereof;
- (c) whether this is being done to give benefits to foreign companies which are producing more costly medicines and if so, the details thereof;
- (d) whether registration of some Indian pharmaceutical companies has been cancelled; and
- (e) if so, the details thereof and the reasons therefor?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY OF SHIPPING AND MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

- (a) to (c): No, Madam. The Core-Committee constituted by the Ministry of Health  and  Family  Welfare  (MoHFW),  Government  of  India  to  revise  the National List of Essential Medicines (NLEM) through a series of meetings and consultations across the country, deliberated and revised the National List of Essential Medicines (NLEM) 2011. There were 348 medicines listed in NLEM 2011. A total  of  106  medicines  have  been  added,  and  70  medicines  have

been deleted while preparing NLEM 2015 which now contain a total of 376 medicines. NLEM 2011 and NLEM 2015 notified by MoHFW were included in Schedule-I of DPCO, 2013 by Department of Pharmaceuticals The apparent mismatch in the total number of medicines is on account of different name of  the  same  medicine  considered  in  NLEM  2011.  The  Core-Committee  has also submitted the detailed recommendations and the procedure adopted for revision of the NLEM. As per NLEM recommendation committee, the criteria for deletion of a medicine are as under:

1. The medicine has been banned in India.
2. If there are reports of concerns on the safety profile of a medicine
3. If medicines with better efficacy or favorable safety profile and better cost-effectiveness is now available.
4. The disease burden for which a  medicine is  indicated  is  no  longer  a national health concern
5. In  case  of  antimicrobials,  if  the  resistance  pattern  has  rendered  a medicine ineffective.
6. (d):  Manufacture,  sale  and  distribution  of  drugs  are  regulated  under provisions  of  Drugs  &  Cosmetics  Act,  1940  and  Rules,  1945  through  a system  of  Licencing  and  inspection.  Licence  for  manufacturing,  sale  & distribution of drugs are granted by the State Licencing Authorities appointed by respective State Governments. The existing regulatory provisions require the  drug  manufacturers  to  comply  with  all  the  conditions  of  license,  which include compliance with Good Manufacturing Practices (GMP) as prescribed under Schedule 'M' of the said Rules, to ensure that the drugs manufactured by them are of standard quality. State Licensing Authorities are empowered to take action on violation of any conditions of such Licenses. Department of Pharmaceuticals has no information regarding cancellation of registration of Indian Pharmaceutical companies
7. (e): In view of reply to (d) above, does not arise.

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