Knowledge Centre

The Directorate General of Foreign Trade (DGFT) has extended the validity of Tariff Rate Quota (TRQ) Authorisations for gold imports under the India-UAE Comprehensive Economic Partnership Ag…

India and Japan have announced a strategic collaboration to accelerate the adoption of Compressed Biogas (CBG) in India, with the ambitious goal of establishing 1,000 biogas plants and suppo…

The Legal Metrology (General) Fourth Amendment Rules, 2026 introduce important changes to the legal metrology framework by updating verification requirements for specified weights and measur…

The Employees' Provident Funds (EPF) Scheme, 2026 replaces the EPF Scheme, 1952 under the Code on Social Security, 2020. The new framework modernizes EPF administration by strengthening digi…

India-Oman CEPA is a proposed bilateral trade agreement aimed at strengthening economic cooperation between India and Oman.

The Delhi Winter Air Pollution Control Directions 2026 establish a permanent winter pollution control framework that will be enforced annually from 1 November to 28 February. The directions …

A well-prepared CDSCO dossier is essential for obtaining regulatory approvals and successfully clearing audits in India. The dossier should include complete product information, manufacturin…

The Delhi Electric Vehicle Policy 2026 introduces a comprehensive framework to accelerate electric mobility by offering purchase incentives, road tax and registration fee exemptions, scrappa…

GST e-invoicing is becoming an increasingly important part of India's Extended Producer Responsibility (EPR) ecosystem by improving transparency, traceability, and verification of recycling …

The Central Drugs Standard Control Organisation (CDSCO) has mandated that all Post-Approval Change (PAC) applications for Registration Certificates and Import Licences of human vaccines and …

Drug labelling mistakes cost manufacturers recalls, import bans, and regulatory notices. This guide covers every CDSCO packaging requirement, from Schedule H red line rules to SUGAM portal a…

A CDSCO pre-submission audit checklist helps medical device companies assess their regulatory readiness before applying for registration or approval in India. The checklist covers key areas …

Outsourcing CDSCO compliance offers significant advantages for startups and importers seeking to navigate India's complex regulatory framework efficiently. By leveraging the expertise of spe…

Starting a manufacturing business in the pharmaceutical, medical device, or healthcare sector is an exciting opportunity, but it also comes with significant regulatory responsibilities. Many…

A CDSCO gap assessment is a systematic review conducted before submitting an application to identify deficiencies that may affect regulatory approval.

India has become one of the fastest-growing healthcare and pharmaceutical markets in the world, attracting manufacturers, importers, and global medical device companies looking to expand the…

Bringing drugs or medical devices to the Indian market involves more than submitting an application. Regulatory requirements, extensive documentation and evolving compliance expectations can…

India's clinical trial ecosystem has changed a lot in recent years. Earlier, getting a new drug approved in India took a very long time. There was too much paperwork and too many delays. But…

Common reasons CDSCO applications get delayed or rejected often include incomplete documentation, incorrect product classification, inconsistencies in submitted data and delayed responses to…

CDSCO approval for cosmetic products in India is mandatory for manufacturers and importers to ensure that cosmetics meet the safety, quality, and labeling requirements prescribed under the C…