Autofits

Autofits logo
Menu

CDSCO Guidelines: India’s Drug Packaging and GMP Framework

CDSCO, the Central Drugs Standard Control Organisation, is India’s national drug regulatory authority, and it enforces the packaging, labelling, and good manufacturing practice requirements that pharmaceutical products made or sold in India must meet. CDSCO operates under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, with GMP requirements set out in Schedule M of those Rules. For packaging, the framework requires that containers and closures protect the product, do not react with it, and carry the prescribed labelling. This is the India-specific counterpart to regimes such as the FDA’s cGMP and EU GMP.

This guide explains what CDSCO is and does, how regulation is split between central and state authorities, what Schedule M requires of manufacturing and packaging, and how a primary-packaging supplier fits into the framework.

Key takeaways

  • CDSCO is India’s national drug regulator, part of the Directorate General of Health Services under the Ministry of Health and Family Welfare, and is headed by the Drugs Controller General of India (DCGI).
  • It regulates under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, supplemented by later rules such as the New Drugs and Clinical Trials Rules, 2019 and the Medical Devices Rules, 2017.
  • Drug regulation in India is shared between CDSCO (central) and the State Licensing Authorities: the states license manufacturing and sale, while CDSCO approves new drugs and imports, sets standards, and coordinates enforcement.
  • Schedule M of the Rules contains the Good Manufacturing Practices and requirements for premises, plant, and equipment, including controls over packaging materials.
  • A revised Schedule M was notified in December 2023, aligning Indian GMP more closely with WHO GMP, with a phased implementation timeline.
  • Labelling of medicines is governed by the labelling rules (for example Rules 96 and 97), and quality standards follow the Indian Pharmacopoeia (IP) where prescribed.

What is CDSCO?

CDSCO is the Central Drugs Standard Control Organisation, the national regulatory authority for pharmaceuticals and medical devices in India. It functions within the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, and is led by the Drugs Controller General of India (DCGI).

CDSCO’s role is to set and enforce national standards for drug quality, safety, and efficacy. Its core functions include approving new drugs and clinical trials, granting import registrations and licences, laying down regulatory measures and standards, and coordinating the activities of the state drug control organisations to bring uniformity across the country. In short, CDSCO is the central pillar of India’s drug regulation, working alongside the states that license day-to-day manufacturing and sale.

How regulation is split: central and state

Drug regulation in India is a shared responsibility: CDSCO handles central functions while the State Licensing Authorities license and inspect manufacturers and sellers in their state. The Drugs and Cosmetics Act, 1940 sets up this dual structure.

  • CDSCO (central). Approves new drugs, fixed-dose combinations, and clinical trials; registers and licenses imports; sets standards and issues guidance; and provides expert bodies and coordination.
  • State Licensing Authorities. Grant manufacturing and sale licences, inspect premises, and enforce quality within the state, applying the same national Act and Rules.

For a packaging manufacturer, this means the licence to operate typically comes from the state authority, while the national standards and the GMP expectations that the licence enforces come from the central framework that CDSCO administers.

What Schedule M requires

Schedule M of the Drugs and Cosmetics Rules is India’s Good Manufacturing Practices standard, covering premises, plant, equipment, quality management, and the control of materials, including packaging materials. It is the Indian equivalent of the GMP codes that other regulators publish, and a manufacturing licence is conditional on meeting it. For packaging, the relevant expectations include:

  • Control of packaging materials. Packaging materials must be stored, handled, sampled, tested, and released under control, so that only approved materials reach the packing line and mix-ups are prevented.
  • Suitable containers and closures. The container closure system must protect the product and must not interact with it in a way that affects its quality, echoing the “not reactive, additive, or absorptive” principle common to GMP regimes.
  • Premises and hygiene. Requirements for premises, plant, equipment, and sanitation appropriate to the dosage form, including cleaner environments for sterile products.
  • Documentation and quality control. Batch records, specifications, and testing that demonstrate consistent quality.

A revised Schedule M was notified in December 2023 to bring Indian GMP closer to the WHO GMP main principles, with a phased implementation window for smaller manufacturers. Labelling of the finished medicine is governed separately by the labelling rules, and product quality standards follow the Indian Pharmacopoeia where a monograph applies.

Where a packaging supplier fits

CDSCO’s GMP framework applies most directly to the drug manufacturer, but a primary-packaging supplier supports it by operating a controlled quality system and supplying qualified, documented components. The drug maker remains responsible for its Schedule M compliance and for qualifying its container closure system, but it relies on suppliers whose materials are consistent and traceable. A seal or cap supplier supports that by manufacturing under a recognised quality system (such as ISO 15378, the GMP-aligned standard for primary packaging materials), by supplying components made from controlled, food-contact-compliant materials, and by providing the specifications, certificates, and documentation the customer needs for its own regulatory file. That documentation is often what a CDSCO-licensed manufacturer relies on during inspection to show its packaging is controlled.

How this works in practice at Autofits

Autofits is an India-based manufacturer of primary packaging (aluminium and aluminium-plastic vial seals and caps) in Nashik, so it operates within India’s regulatory framework and supplies CDSCO-licensed pharmaceutical customers as well as exporters. Autofits runs an ISO 15378:2017 quality system, the GMP-aligned standard for primary packaging materials, alongside ISO 9001:2015 and ISO 14001:2015 certification, a Drug Master File (DMF 18100), and CFDA registration (B20200000501). The FlipTop Optima flip-off seals, tear-off and tear-down aluminium seals, and aluminium pilfer-proof (ROPP) caps are made from controlled materials, AA8011 aluminium alloy, epoxy lacquer conforming to 21 CFR 175.300, and polypropylene conforming to 21 CFR 177.1520, with heavy metals held to a maximum 100 ppm total and BSE/TSE-free status. Production runs in a 75,000 sq ft facility with an ISO Class 8 cleanroom and high-speed visual inspection, with the specifications and documentation that a CDSCO-licensed customer needs to show its packaging is controlled.

Frequently asked questions

What is CDSCO?

CDSCO is the Central Drugs Standard Control Organisation, India’s national drug regulatory authority. It sits within the Directorate General of Health Services under the Ministry of Health and Family Welfare and is headed by the Drugs Controller General of India (DCGI). It approves new drugs and imports, sets national standards, and coordinates enforcement with the state drug control organisations.

Which laws does CDSCO enforce?

CDSCO enforces the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, supplemented by later rules such as the New Drugs and Clinical Trials Rules, 2019 and the Medical Devices Rules, 2017. Good Manufacturing Practices are set out in Schedule M of the Rules.

What is Schedule M?

Schedule M of the Drugs and Cosmetics Rules is India’s Good Manufacturing Practices standard. It covers premises, plant, equipment, quality management, and the control of materials, including packaging materials. A manufacturing licence is conditional on meeting Schedule M. A revised Schedule M was notified in December 2023 to align Indian GMP more closely with WHO GMP, with a phased implementation.

Does CDSCO regulate packaging materials?

Packaging is covered within the GMP framework rather than by a single standalone rule. Schedule M requires packaging materials to be controlled, and requires the container closure system to protect the product without interacting with it. Labelling of the finished medicine is governed by the labelling rules. A drug maker remains responsible for qualifying its packaging.

How does a packaging supplier support CDSCO compliance?

A primary-packaging supplier supports its customers’ compliance indirectly: by manufacturing under a recognised quality system such as ISO 15378, supplying components from controlled, food-contact-compliant materials, and providing the specifications, certificates, and documentation the customer needs for its own regulatory file and inspections. The CDSCO-licensed drug manufacturer remains responsible for its own GMP compliance.

Related reading

Sources

  • CDSCO: Central Drugs Standard Control Organisation, official site (https://cdsco.gov.in/opencms/opencms/en/Home/)
  • CDSCO: The Drugs and Cosmetics Act, 1940 and Rules, 1945 (https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf)
  • Ministry of Health and Family Welfare: Gazette notification of the revised Schedule M, December 2023 (https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/)

“`json { “@context”: “https://schema.org”, “@graph”: [ { “@type”: “Article”, “headline”: “CDSCO Guidelines: India’s Drug Packaging and GMP Framework”, “description”: “CDSCO is India’s national drug regulator. It enforces the Drugs and Cosmetics Rules, Schedule M GMP, and labelling rules that govern pharmaceutical packaging made or sold in India.”, “author”: {“@type”: “Organization”, “name”: “Autofits Technical Team”}, “publisher”: { “@type”: “Organization”, “name”: “Autofits Packaging Pvt. Ltd.”, “address”: { “@type”: “PostalAddress”, “streetAddress”: “E-13/7/4, MIDC, Malegaon, Sinnar”, “addressLocality”: “Nashik”, “addressCountry”: “IN” } }, “datePublished”: “2026-07-06”, “dateModified”: “2026-07-06” }, { “@type”: “FAQPage”, “mainEntity”: [ {“@type”: “Question”, “name”: “What is CDSCO?”, “acceptedAnswer”: {“@type”: “Answer”, “text”: “CDSCO is the Central Drugs Standard Control Organisation, India’s national drug regulatory authority. It sits within the Directorate General of Health Services under the Ministry of Health and Family Welfare and is headed by the Drugs Controller General of India (DCGI). It approves new drugs and imports, sets national standards, and coordinates enforcement with the state drug control organisations.”}}, {“@type”: “Question”, “name”: “Which laws does CDSCO enforce?”, “acceptedAnswer”: {“@type”: “Answer”, “text”: “CDSCO enforces the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, supplemented by later rules such as the New Drugs and Clinical Trials Rules, 2019 and the Medical Devices Rules, 2017. Good Manufacturing Practices are set out in Schedule M of the Rules.”}}, {“@type”: “Question”, “name”: “What is Schedule M?”, “acceptedAnswer”: {“@type”: “Answer”, “text”: “Schedule M of the Drugs and Cosmetics Rules is India’s Good Manufacturing Practices standard. It covers premises, plant, equipment, quality management, and the control of materials, including packaging materials. A manufacturing licence is conditional on meeting Schedule M. A revised Schedule M was notified in December 2023 to align Indian GMP more closely with WHO GMP, with a phased implementation.”}}, {“@type”: “Question”, “name”: “Does CDSCO regulate packaging materials?”, “acceptedAnswer”: {“@type”: “Answer”, “text”: “Packaging is covered within the GMP framework rather than by a single standalone rule. Schedule M requires packaging materials to be controlled, and requires the container closure system to protect the product without interacting with it. Labelling of the finished medicine is governed by the labelling rules. A drug maker remains responsible for qualifying its packaging.”}}, {“@type”: “Question”, “name”: “How does a packaging supplier support CDSCO compliance?”, “acceptedAnswer”: {“@type”: “Answer”, “text”: “A primary-packaging supplier supports its customers’ compliance indirectly: by manufacturing under a recognised quality system such as ISO 15378, supplying components from controlled, food-contact-compliant materials, and providing the specifications, certificates, and documentation the customer needs for its own regulatory file and inspections. The CDSCO-licensed drug manufacturer remains responsible for its own GMP compliance.”}} ] }, { “@type”: “BreadcrumbList”, “itemListElement”: [ {“@type”: “ListItem”, “position”: 1, “name”: “Standards”, “item”: “/standards/”}, {“@type”: “ListItem”, “position”: 2, “name”: “CDSCO Guidelines”, “item”: “/standards/cdsco-guidelines/”} ] } ] } “`

*Last updated: 2026-07-06. This article is general regulatory information, not legal or compliance advice; confirm current regulatory text and requirements with CDSCO and the applicable State Licensing Authority.*

Back to top: