Loan License vs Own Manufacturing License in India: Which Route Is Right for Your Medical Device Business?
One of the most consequential decisions a Medical Device company faces when entering the Indian manufacturing landscape is whether to establish its own licensed manufacturing facility or to operate under a loan license arrangement. Both routes are fully legitimate under India’s Medical Devices Rules, 2017 (MDR 2017), and each carry […]
Read MoreIndia’s Biological Regulatory Ecosystem Explained: CDSCO, RCGM, GEAC, DBT, NIB & Beyond
Why India’s Regulatory System is Different For companies entering India with Biological products for the first time, one of the most frequent surprises is the multiplicity of Regulatory authorities involved in approval, oversight, and commercialisation. Unlike the US FDA — a single agency with comprehensive jurisdiction over Biologics — India’s […]
Read MoreCDSCO Online Portal (SUGAM) Guide for Drug Import Applications
Learn how to use the CDSCO SUGAM Portal for Drug Import applications in India. This guide explains registration, application submission, document requirements, and compliance steps for smooth regulatory approval. The CDSCO SUGAM Portal has transformed the Drug Import approval process in India by providing a centralized online platform for regulatory […]
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Top 10 Reasons Biological Product Approvals Get Delayed in India — And How to Avoid Them
Time Is Money — And Preventable Delays Are Common India’s Biological product approval timelines are frequently longer than companies anticipate. While CDSCO has made significant progress in recent years — introducing electronic submissions, faster SEC meeting schedules, and more transparent communication — delays remain prevalent, and most of them are […]
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Schedule M GMP: Are Indian Pharmaceutical Manufacturers Really Ready?
The revision of Schedule M to India’s Drugs and Cosmetics Act represents one of the most consequential regulatory changes for domestic Pharmaceutical manufacturers in recent memory. Notified by the Ministry of Health and Family Welfare, the revised Schedule M aligns Indian GMP requirements substantially more closely with WHO Technical Report […]
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“The BIS–CDSCO Connection: Why Ninth Schedule Compliance Can Make or Break Your Cosmetic Import Registration in India”
Two Bodies, One Compliance Decision Most global Cosmetic brands entering India are familiar with CDSCO as the gatekeeper for Import registration. Far fewer understand the parallel role of the Bureau of Indian Standards (BIS) — and fewer still understand how CDSCO reviewers actively cross-reference BIS compliance during the COS 1 […]
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What Investors and PE Firms Actually Look for in Pharmaceutical Regulatory Due Diligence
Private equity investment in India’s Pharmaceutical sector has accelerated substantially. The combination of a large domestic market, globally competitive manufacturing, and India’s strategic position as a supplier of generic medicines to regulated markets worldwide has attracted significant capital from Domestic and International PE firms, strategic investors, and sovereign wealth funds. […]
Regulation/Guidelines
Manufacturing License for Sale or for Distribution of Medical Devices in India: MD-3, MD-5, MD-7, and MD-9 Made Simple
India’s Medical Device manufacturing sector is growing rapidly, driven by a combination of government policy, the Make in India initiative, and increasing global demand for cost-effective, high-quality medical products. For any company wishing to manufacture Medical Devices in India — whether domestic or foreign — obtaining the correct manufacturing license […]
Regulation/Guidelines
Banned and Restricted Cosmetic Ingredients in India: The Updated List Every Global Brand Must Know
The Ingredient Compliance Imperative For global Cosmetic brands, formulation approval in one major market — the EU, the US, or Japan is often viewed as a strong indicator of product safety and compliance. In India, this assumption can be costly. The Indian regulatory framework maintains its own list of banned and restricted Cosmetic ingredients, and […]