Indian pharma exports secured 11th position globally in 2023, says Minister

New Delhi: Indian pharma exports secured the 11th position in the world in value terms in 2023, accounting for 3 per cent of total pharmaceutical exports, Union Minister Anupriya Patel said in the Rajya Sabha on Tuesday.

In a written reply to the House, the minister has cited a secondary market research analysis conducted by Bain and Company earlier this year.

In a reply to a question, Patel has said the mobile app of National Pharmaceuticals Pricing Policy (NPPP), Pharma Sahi Daam (PSD) provides brand name, composition, ceiling price and maximum retail price of drugs for consumer benefit and transparency.

As per PTI report, she said the entire procedure of price fixation in accordance with extant policy is available in the public domain, ensuring transparency and accountability, and no change in this regard is under consideration.

Replying to a query on whether the quality of Indian pharmaceutical products has often been questioned in some global markets, the minister said the Central Drugs Standard Control Organisation (CDSCO) and Ministry of Health and Family Welfare have taken several measures to ensure quality, safety and efficacy of medicines.

Medical Dialogues team had earlier reported that over 400 enforcement actions, including show cause notices, production stoppages, and license cancellations, had been taken against drug manufacturers for regulatory violations under the Drugs Rules, 1945.

She had elaborated that Central Drugs Standard Control Organization (CDSCO) and Ministry of Health and Family Welfare had taken several measures to ensure quality, safety and efficacy of medicines in the country, as stated below:

(i). In order to assess the regulatory compliance of drug manufacturing premises in the country, the Central Drugs Standard Control Organization (CDSCO) along with State Drugs Controllers (SDCs) had initiated risk-based inspections of Drug manufacturing firms from Dec 2022. Risk-based inspections of more than 500 premises have been conducted so far. Drug manufacturing firms have been identified based on risk criteria like number of drugs declared as Not of Standard Quality, complaints, criticality of the products etc. Based on findings of inspections, more than 400 actions like issuance of show cause notices, stop production order, suspension, cancellation of licenses /product licenses etc., have been taken by the State Licensing Authorities as per the provisions of the Drugs Rules 1945.    

(ii). Central Government has amended the Drugs Rules 1945 vide G.S.R. 922 (E) dated 28.12.2023 to revise the schedule M to the said rules related to Good Manufacturing Practices and requirements of premises, plant and equipment for pharmaceutical products. Revised Schedule M has become effective for the drug manufacturers with turnover>250 crores from 29.06.2024. However, for manufacturers having turnover of less than 250 Cr, draft rules have been published vide GSR 10(E) dated 04.01.2025 regarding extension of timelines till 31st December, 2025.

(iii). On 17.11.2022, the Drugs Rules, 1945 were amended vide G.S.R. 823(E) which has come into force from 1st of August, 2023 providing that the manufacturers of top 300 brands of drug formulation products, as specified in Schedule H2, shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication.

(iv). On 18.01.2022, the Drugs Rules, 1945 were amended vide G.S.R. 20 (E) providing that every Active Pharmaceutical Ingredient (bulk drug) manufactured or imported in India shall bear Quick Response Code on its label at each level of packaging that store data or information readable with software application to facilitate tracking and tracing. The stored data or information shall include the minimum particulars including unique product identification code, Batch Number, Manufacturing date, Expiry Date etc.

(v). On 11.02.2020, the Drugs Rules, 1945 were amended vide G.S.R. 101 (E), providing that with effect from 01.03.2021, any marketer who sells or distributes any drug shall be responsible for quality of that drug as well as other regulatory compliances along with the manufacturer under these Rules.

(vi). The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics (Amendment) Act 2008 to provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and nonbailable.

(vii). States/ UTs have set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal.

(viii). To ensure efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been 1`amended providing that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing license of oral dosage form of some drugs.

(ix). The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority.

(x). The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been significantly increased in last 10 years.

(xi). Central regulator coordinates activities of State Drug Control Organisations and provides expert advice through the Drugs Consultative Committee (DCC) meetings held with State Drugs Controllers for uniformity in administration of the Drugs and Cosmetics Act.

(xii). Central government is providing regular residential, regional training and workshops to officials of CDSCO and State Drug Regulatory Authorities on Good Manufacturing Practices. In the Financial Year 2023-24 CDSCO has trained 22854 persons while in Financial Year 2024-25, so far 13007 persons have been trained.

(xiii). Further, Department of Pharmaceuticals is implementing a Scheme, viz., ‘Revamped Pharmaceuticals Technology Upgradation Scheme’ (RPTUAS), with a view to facilitate existing Pharma units to upgrade to ‘Revised Schedule M’ and ‘WHO-GMP’ standards, enhancing the quality and safety of pharmaceutical products manufactured in our country. The tenure of the scheme is from F.Y 2021-22 to 2025-26 with the total outlay of Rs. 300.10 crores.