Knowledge Centre

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…

Schedule M is a part of the Drugs and Cosmetics Rules 1945, and lays down the Good Manufacturing Practices (GMP) requirements for pharmaceutical manufacturing facilities in India.

The Mineral Conservation and Development (Amendment) Rules, 2026, which modify some of the Mineral Conservation and Development Rules, 2017, have been announced by the Central Government in …

The Ecomark is the government certification eco-label in India that helps in recognizing products that are environmentally safe. It is hoped that the recommended amendments will help India s…

Applications for approval to import a medical Device into India are authorized by the Central Drugs Standards Control Organization (CDSCO). According to the guidelines outlined in the Medica…

CDSCO regulations include four main types of licenses - the Manufacturing License, Import License, Test License, and Loan License. Each license plays a specific role in India's regulatory la…

An ISO 13485 Certificate serves as the vital backbone for a trusted Medical Device QMS (Quality Management System). This global benchmark ensures that every surgical tool or machine remains …

An FSSAI License is a mandatory food safety certification that gives companies a 14-digit identification number via the Food Safety and Standards Authority of India (FSSAI) website.

In June 2026, SEBI released the SEBI Master Circular for AIFs 2026. This one document replaced all old rules. It now serves as the single compliance guide for Alternative Investment Fund reg…

CDSCO registration is the obligatory process through which Indian as well as foreign drug, medical device, or cosmetic firms are entitled to market their drug, medical device, or cosmetic in…