Lok Sabha Question No. 5007 (UNSTARRED), answered on 2023-03-31
Subject: Accessibility of Quality Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Vincent H Pala

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO.5007 TO BE ANSWERED ON 31 ST  MARCH, 2023

## ACCESSIBILITY OF QUALITY MEDICINES

## 5007: SHRI VINCENT H. PALA:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether the price of various drug portfolios has increased despite active regulation of the price of drugs and if so, the details thereof and the reasons therefor;
- (b) whether the medicine accessibility in rural India has not been scaled up even after a large spending on schemes such as Ayushman Bharat and if so, the details thereof along with the reasons therefor;
- (c) whether the Government is aware that branded drugs under the AMRIT pharmacies are not available and if so, the details thereof along with the reasons therefor;
- (d)  whether  the  pharmacist-to-patient  ratio  across  rural  India  stands  at  one  pharmacist  for 4000 people and if so, the details thereof along with the steps taken by the Government to improve medical assistance in pharmacies that are understaffed;
- (e)  whether  the  Government  proposes  to  take  measures  to  address  issues  such  as  lack  of storage facilities and poor infrastructure for the movement of medicines from source to endconsumer affecting medicine accessibility; and
- (f) if so, the details thereof and if not, the reasons therefor?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

(a) to (d): As per the information provided by Department of Pharmaceuticals (DoP), the National  Pharmaceutical  Pricing  Authority  (NPPA)  under  DoP  fixes  the  ceiling  price  of medicines  specified  in  the  first  schedule  of  Drugs  (Prices  Control)  Order,  2013  (DPCO, 2013).  All  manufacturers  of  medicines  have  to  sell  their  products  within  the  ceiling  price (plus applicable Goods and Service Tax) fixed by the NPPA. The annual increase allowed in the case of Scheduled formulations is upto the level of annual revision in Wholesale price index  (WPI).  NPPA  also  fixes  retail  price  of  a  new  drug  under  DPCO,  2013  for  existing manufacturers of scheduled formulations. The notified retail prices are applicable only to the applicant  manufacturing/  marketing  companies.  For  other  non-scheduled  formulations,  a manufacturer  is  at  liberty  to  fix  the  maximum  retail  price  of  a  non-scheduled  formulation launched by it. In case of non-scheduled formulation, no manufacturers can increase MRP by more than 10% of MRP during preceding 12 months. Instances of overcharging are dealt with by NPPA under the relevant provisions of DPCO, 2013. In addition, Para 19 of DPCO, 2013 provides for fixation of  ceiling  price  or  retail  price  of  any  drug  in  public  interest  for  such period, as deemed fit, in case of extra-ordinary circumstances.

To supplement States' efforts, National Health Mission (NHM), has launched the Free Drugs Service Initiative to provide free medicines to healthcare seekers at all levels of the public health system. NHM provides budgetary support to the States/UTs through Program Implementation Plans (PIPs).

Under  Ayushman  Bharat  Pradhan  Mantri  Jan  Arogya  Yojana  (AB  PMJAY), Empanelled  Health  Care  Providers  (EHCP)  are  paid  as  per  specified  package  rates.  A package  consists  of  all  the  costs  associated  with  the  treatment,  including  pre  and  post hospitalisation expenses. These are bundled packages which include all aspects of treatment including pre-admission diagnostics and post discharge medicines for 15 days. The treatment packages  include  super  speciality  care  like  oncology,  neurosurgery,  cardio-thoracic  and cardiovascular surgery. Ayushman Bharat Pradhan Mantri Jan Arogya Yojana has facilitated the availability of free medicines to eligible beneficiaries availing healthcare services under the scheme.

AMRIT Pharmacies are acting as a single point of supply for medical requirements of the hospitals including Branded/Branded Generic/Generic drugs, surgical items, consumables and implants especially for tertiary care hospitals. AMRIT Pharmacy keeps stock of 01 (one) Branded Stock Keeping unit (SKU) and one or two Branded Generic/Generic SKUs for a composition and strength as per the prescription pattern of the Hospital and of the General public of that locality.

Since  2014,  the  number  of  institutes  approved  by  The  Pharmacy  Council  of  India (PCI) for Diploma in Pharmacy (D.Pharm) has increased from 710 to 3333 and for Degree in Pharmacy (B.Pharm), it has increased from 930 to 2411.

(e) & (f): The Government of India takes measures for ensuring that the quality, safety and efficacy of medicines are not compromised from source to end-consumer. With this in view,  the  Government  has  taken  a  series  of  measures  including  strengthening  of  legal provisions,  workshops  and  training  programmes  for  manufacturers  and  regulatory  officials and measures such as risk based inspections.

These aspects include procurement, storage, distribution, transportation, documentation and record-keeping practices. However, sales, stock and distribution of drugs in  the  country  are  regulated  under  the  provisions  of  Drugs  &  Cosmetics  Act,  1940  by  the State  Licensing  Authorities  (SLAs)  appointed  by  the  respective  States/UTs  Governments. The SLAs are legally empowered to take stringent action in case of any non-compliance.

******