CDSCO issues guidance on trial approvals with an eye on e-submissions

By Gareth Macdonald

- Last updated on GMT

Related tags: Clinical trials, Pharmacology

India’s Central drugs standard control organisation (CDSCO) has issued new draft guidance of clinical trials and new drug approvals that pave the way for potential electronic submissions.

The document, available here, covers the requirements for approval of trials, new drugs and details the CDSCO’s review process under Rule 122A, 122B, 122DA,122DAA,122E and Schedule-Y of the Drugs and Cosmetics Rule.

The organisation said that: “This guidance will help the industry to submit the required documents in a more realistic manner, which in turn will also help reviewer of CDSCO to review such application in systematic manner.

It is apparent that this structured application with comprehensive and rational contents will help the CDSCO to review and take necessary actions in a better way and would also ease the preparation of electronic submissions, which may happen in the near future at CDSCO​.”

The issuance of the new document, which covers the differing requirements for clinical trials for drugs discovered in India compared with those discovered elsewhere, follows just a month or so after the CDSCO updated its rules on adverse events during studies​.

Import export APIs

In addition the new guidance, issued during a busy​ week for the CDSCO regulatory team, clarifies the organisations rules on the importation of active pharmaceutical ingredients (APIs) for both clinical trials and the market.

It specifies that applicants importing small quantities of APIs for clinical trials under the Form 11 registration process must also provide a Form 12 approval document.

Similarly, manufacturers can produce small quantities of API for trials provided that the have obtained a Form 29 license issued by state authorities.

The document also advises that applicants seeking to obtain APIs for trials from a third party manufacturer not yet approved by the DCGI need the supplier in question to seek a DSCO no objections certificate (NOC).

Related news

Show more

Related products

show more

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Baxter BioPharma Solutions | 05-Nov-2018 | Technical / White Paper

Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical....

Baxter’s Oncology Contract Manufacturing

Baxter’s Oncology Contract Manufacturing

Baxter BioPharma Solutions | 29-Aug-2018 | Product Brochure

Baxter BioPharma Solutions’ FOYA award-winning facility in Halle/Westfalen, Germany, offers state-of-the-art parenteral cGMP manufacturing at one location,...

Related suppliers

Follow us

Featured Events

View more


View more