A Review on the Regulatory Study for Implementation of Schedule-M Amendments in Pharmaceutical Industries in India

Year : 2026 | Volume : 13 | 02 | Page :
    By

    Sahil Sanjay Varpe,

  • Aishwarya Bhandare,

  • Atish Velhal,

  • Prakash Jadhav,

  1. , Dr. Babasaheb Ambedkar Technological University, Lonere, Maharashtra, India
  2. , Dr. Babasaheb Ambedkar Technological University, Lonere, Maharashtra, India
  3. , Dr. Babasaheb Ambedkar Technological University, Lonere, Maharashtra, India
  4. , Dr. Babasaheb Ambedkar Technological University, Lonere, Maharashtra, India

Abstract

A major regulatory change in pharmaceutical manufacturing industry in India is the introduction of the updated Schedule M (2023–2024). The aims to compliance the country’s Good Manufacturing Practices (GMP) with international quality standards. The review evaluates the Schedule M amendments implementation strategies, industrial impact and regulatory relevance. Legislative texts, official notices, WHO GMP reports, ICH guidelines, guidance documents of CDSCO and peer-reviewed literature were all explored as part of the qualitative regulatory research process. A systematic 13-part framework that focuses on quality risk management, pharmaceutical quality systems, computerized systems, validation, and continuous improvement is introduced in the updated Schedule M. Government assistance programs like PPDS, PTUAS/RPTUAS, and APICF are essential for allowing shared infrastructure, development of regulatory capacity and technology upgrades especially for MSMEs. These improvements are projected to improve product quality, patient safety, export readiness, and international regulatory confidence, covering implementation challenges related to cost and technical preparedness. The review comes to the inference that India’s pharmaceutical regulatory ecosystem and long-term global market competitiveness are significantly strengthened by the updated Schedule M, which is supported by specific governmental measures.

Keywords: Schedule M, WHO, USFDA, EMA, CDSCO, Good Manufacturing Practices.

How to cite this article:
Sahil Sanjay Varpe, Aishwarya Bhandare, Atish Velhal, Prakash Jadhav. A Review on the Regulatory Study for Implementation of Schedule-M Amendments in Pharmaceutical Industries in India. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2026; 13(02):-.
How to cite this URL:
Sahil Sanjay Varpe, Aishwarya Bhandare, Atish Velhal, Prakash Jadhav. A Review on the Regulatory Study for Implementation of Schedule-M Amendments in Pharmaceutical Industries in India. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2026; 13(02):-. Available from: https://journals.stmjournals.com/rrjodfdp/article=2026/view=243593


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Ahead of Print Subscription Review Article
Volume 13
02
Received 19/04/2026
Accepted 01/05/2026
Published 10/05/2026
Publication Time 21 Days
22

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