Who regulates medicines in India?
CDSCO, headed by the Drugs Controller General of India (DCGI), is the national regulator for medicines and clinical trials. Manufacturing, import, sale and distribution of drugs are governed by the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. New drugs and clinical trials are governed by the New Drugs and Clinical Trials Rules, 2019. State drug-control authorities license and inspect sale and manufacture.
An approved medicine has been authorised for a defined formulation, manufacturer, indication and route. A research peptide catalogue record has none of those approvals.
Research-use-only materials versus medicines
Research peptides are supplied as laboratory materials for in-vitro and preclinical research. They are labelled for research use only and not for human consumption. They are not sold as medicines, supplements, cosmetics or treatments, and suppliers should not make therapeutic claims for them.
Using an unapproved material in people, or marketing it as a treatment, raises very different legal questions from laboratory research. Clinical research in people requires the approvals and ethics oversight set out in the clinical-trial rules.
What this means for buyers
Check that a supplier presents materials as research-use-only, avoids treatment and dosing claims, provides a traceable business identity in India and can supply batch documentation. Keep your order and batch records with your research records.
Rules can change and can apply differently to particular compounds, institutions and uses. If you need certainty for a particular use, consult a qualified legal professional and the current CDSCO notifications.
How The Peptide Co. operates
The Peptide Co. is based in Bengaluru, Karnataka and lists materials for laboratory research use only, with INR pricing, private batch documentation on request and order confirmation on WhatsApp. We do not provide dosing, administration or medical advice.
We may decline an order request that is incomplete, not serviceable or raises compliance or safety concerns.