Parliament Question: Market Access Programmes by Pharma Companies

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 981 TO BE ANSWERED ON24THJULY, 2026 MARKETACCESSPROGRAMMESBYPHARMACOMPANIES

981.SHRIK C VENUGOPAL:

Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:

(a) the details of guidelines governing the conduct of market access and patient assistance programmesbypharmaceutical companiesinprivate hospitals;

(b) the institutional mechanismsinplace tomonitorthese programmes, the use of patientdata andthe outcomes generatedtherefrom, alongwith the specific role playedby the State Health Departmentsinthisregard; and

(c) the measures taken by the Government to ensure that pharmaceutical companies do not influence the pricing mechanisms or the inclusion of high-end drugs and diagnostics in the benefitpackagesof Central andStatehealthinsurance schemes? ANSWER THE MINISTER OFHEALTH AND FAMILYWELFARE (SHRIJAGATPRAKASH NADDA)

(a)& (b): As informed by Department of Pharmaceuticals (DoP), the pharmaceutical companies implement Patient Assistance Programmes (PAPs)/Market Access Programmes as voluntary initiatives to improve patient access and affordability of innovative medicines.

These programmes are administered through independent third-party agencies based on defined patient eligibility criteria and company-specific operating procedures, with appropriate safeguards, including oversight mechanisms, periodic audits and grievance redressal systems.

As informedby Department of Pharmaceuticals (DoP),the pharmaceutical companies have established internal oversight and control mechanisms for the implementation of PAPs, including verification of patient eligibility and prescriptions, monitoring of third-party agencies, confirmation of drug administration and periodic independent audits. Patient information is collected and processed by the third-party agencies only for programme administrationandtreatment continuity.(c): As informed by Department of Pharmaceuticals (DoP), the National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals fixes ceiling prices of formulations and medical devices included in the National List of Essential Medicines published by the Ministry of Health and Family Welfare and incorporated by the DoP in Schedule-I to the Drugs (Prices Control) Order, 2013 (DPCO, 2013). NPPA also fixes the retail price of new drugs as defined in section 2(1) (u) of DPCO, 2013. In case of non- scheduled formulations, manufacturers are required to not increase the maximum retail price

(MRP) of such formulations by more than 10% of MRP during preceding 12 months. NPPA monitors the prices of both scheduled and non-scheduled formulations/medical devices and takes action in accordance with the provisions of DPCO, 2013 against companies that are found overcharging consumers.

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