Contract, document and compliance management for pharma and healthcare

Manufacturing partners: revised Schedule M is now binding on everyone

Revised Schedule M to the Drugs Rules, 1945, the good manufacturing practice schedule, was notified on 28 December 2023. An amendment of 11 February 2025 let small and medium manufacturers with turnover under ₹250 crore apply for an extension to 31 December 2025; that date has passed, so every manufacturer is now within the revised schedule. Loan-licence, contract-manufacturing and API supply agreements should warrant compliance with the revised schedule and give the brand owner audit rights and visibility of any upgrade plan.

Licences are perpetual only while the retention fee is paid

Under rule 63 of the Drugs Rules, 1945, sale and distribution licences remain valid only if the licence retention fee is paid before the end of each five-year period; late payment attracts a surcharge for up to six months, after which the licence is deemed cancelled. Manufacturing licences and medical-device licences follow the same perpetual-with-retention-fee model. A distribution or supply agreement that asks for a licence copy at signature misses the point; it should require evidence of retention-fee payment every five years, and the compliance calendar should carry the due date.

• IntelloVault stores each partner's licence with its form number and retention-fee due date extracted.
• IntelloComply raises the retention-fee obligation to the owner months ahead, with the receipt attached as evidence when paid.

Clinical trial agreements the ethics committee must see

The New Drugs and Clinical Trials Rules, 2019 require ethics committee approval from a registered committee before a trial begins, an undertaking by the sponsor to compensate trial-related injury or death, and submission to the committee of a defined document set that includes the investigator's agreement with the sponsor and the investigator's undertaking. Sponsor, CRO, site and investigator agreements therefore need the compensation undertaking, insurance, committee-registration warranties and protocol-deviation controls written in, and the agreement itself has to be ready before the committee meets.

Doctor engagement under UCPMP 2024

The Department of Pharmaceuticals issued the Uniform Code for Pharmaceutical Marketing Practices 2024 on 12 March 2024. According to the Department, companies are accountable for the actions of their medical representatives and employees; gifts, monetary benefits and hospitality to doctors and their families are prohibited; companies must self-declare adherence and disclose expenditure on conferences, seminars and workshops for continuing medical education; and penalties include reprimand with publication, recovery of money or items given, and corrective statements in the media. Consultancy, speaker, advisory-board and CME-sponsorship agreements need documented fees, no hospitality to family members, expenditure disclosure and audit rights, and representative and distributor contracts should bind them to the code.

Hospitals and clinics: registration and patient data

The Clinical Establishments (Registration and Regulation) Act, 2010 applies in the states and union territories that have adopted it, with provisional registration by self-declaration followed by permanent registration against minimum standards, and the central rules require rates for each service to be displayed. Under the Digital Personal Data Protection Act, 2023, health data is personal data like any other; section 8 makes the hospital or company, as data fiduciary, responsible for processing done on its behalf regardless of any agreement, and allows a processor to be engaged only under a valid contract. Every IT, claims, laboratory or CRO vendor that touches patient data therefore needs a written processing contract, and the Act's rules, notified on 13 November 2025, bring the substantive duties into force by 13 May 2027.

Why one platform

The licence, the partner, the agreement and the obligation belong together. IntelloSync keeps the contract, the vendor record, the obligation and the evidence on one repository with one permission model. IntelloContract drafts and negotiates agreements as real Word documents, routes approvals and executes with Aadhaar eSign, DSC or virtual signatures and e-stamping. IntelloVendor onboards and risk-scores third parties. IntelloComply puts statutory and contractual obligations on a calendar with owners, reminders, evidence and an audit trail. IntelloVault stores and indexes every signed document. Pricing is per module with unlimited users, and the platform is ISO/IEC 27001:2022 certified.