Lok Sabha Question No. 4551 (UNSTARRED), answered on 2021-03-23
Subject: Monitoring Mechanism for Drug Supply
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Sajda Ahmed

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

LOK SABHA UNSTARRED QUESTION NO. 4551 TO BE ANSWERED ON 23 rd  March, 2021

Monitoring Mechanism for Drug Supply

## 4551.   SHRIMATI SAJDA AHMED:

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

- (a)  whether  the  Government  has  adopted  any  monitoring  mechanism  with  real-time  drug production and supply in domestic market and if so, the details thereof;
- (b) whether the Government has taken note that during the pandemic, supply chain of essential drug was broken in rural areas and if so, the details thereof;
- (c)  whether  the  Government proposes any policy  to ensure nationwide  sufficient access of drugs including rural areas in view of future pandemic situation and if so, the details thereof; and
- (d)  whether  there  is  any  existing  mechanism  to  monitor  medicine  outlets  to  confirm  the availability of drugs and if so, the details thereof?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI D. V. SADANANDA GOWDA)

(a): National Pharmaceutical Pricing Authority (NPPA)  under the Department of Pharmaceuticals (DoP) implements and enforce the provisions of the Drugs (Prices Control) Orders in accordance with the powers delegated to it.  There is a mechanism of monitoring the production and availability of the essential drugs/ scheduled drugs under para 21 (1) the Drugs (Prices Control) Order, 2013 (DPCO, 2013) that provides for submission of quarterly return in respect of production/ import and sales of scheduled medicines and Active Pharmaceutical Ingredients (APIs) contained in scheduled formulations as stated in Form-III of Schedule-II of the DPCO, 2013 by a manufacturer/ importer/ marketer. Further, any manufacturer/importer wanting to discontinue manufacture / import of a scheduled formulation has to apply to NPPA in Form-IV of Schedule-II of the DPCO, 2013 at least 6 months in advance, and NPPA can direct the applicant to continue production / import up to one year.

NPPA monitors shortage & non-availability of drugs on the basis of reports received from the State Drugs Controllers and complaints, if any, received from individuals. On receipt of such reports, NPPA immediately takes up the matter with the concerned manufacturer and advise them to rush the stock in the affected area.  NPPA under the Consumer Awareness, Publicity and Price Monitoring (CAPPM) Scheme has set up Price Monitoring and Resource Units (PMRUs) in the State/ Union Territories. Till now, PMRUs have been set up in seventeen (17)  States.  Under  the  CAPPM  Scheme  advertising  &  publicity  campaign/  seminars/ workshops/ webinars etc. are organised from time to time. Apart from this, consumers are made aware about the price fixation and availability of medicines.

(b): As  per  information  provided  by  the Central  Drugs  Standard  Control  Organisation ( CDSCO ) under the Ministry of Health & Family Welfare, the CDSCO has not received any report  that  supply  chain  of  essential  drugs  was  broken  in  rural  areas  during  the  pandemic. Through  greater  interaction  with  the  industry  associations,  manufacturers  as  well  as  state authorities, the Department of Pharmaceuticals took steps to ensure that supply chains were not compromised during lockdown and unlock phases.

Further, NPPA constituted an inter-ministerial Committee to monitor trends of export and import of APIs/Formulations and Medical Devices to ensure timely  availability of key drugs, assess bottlenecks and impediments in imports of APIs and suggest possible alternative sources  &  export  trend  analysis  to  ensure  domestic  availability  of  key  drugs  and  Medical Devices  during  the  pandemic.  Control  Rooms  were  also  set  up  by  the  Department  of Pharmaceuticals and NPPA to ensure seamless availability of drugs.

(c) & (d): National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals, as an ongoing process, regularly monitors the production and availability of drugs under para 21 of the DPCO, 2013.

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