Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

DR REDDYS LABORATORIES LTD Regulatory Filings 2021

Jul 2, 2021

30528_rns_2021-07-02_c5ff86b0-5497-44db-80e5-83cf076fa2a6.pdf

Regulatory Filings

Open in viewer

Opens in your device viewer

==> picture [136 x 31] intentionally omitted <==

Dr. Reddy's Laboratories Ltd. 8-2-337, Road No. 3, Banjara Hills, Hyderabad – 500 034, Telangana, India. CIN : L85195TG1984PLC004507 T: +91 40 4900 2900 F: +91 40 4900 2999 Email: [email protected] www.drreddys.com

July 2, 2021

Surveillance Department BSE Limited Dalal Street, Fort Mumbai – 400 001 Fax Nos.: 022-22723121 / 22723719

Scrip Code: 500124

Dear Sirs,

Ref.: Your email dated July 01, 2021

Sub: Verification -July 01, 2021 -DR.REDDY'S LABORATORIES LTD. (500124)

This is with reference to your email dated July 1, 2021, seeking clarification/confirmation on news item appearing in the “Website-www.economictimes.com” dated July 01, 2021 captioned “Dr Reddy's Labs denied approval for final trial of Russian-made Sputnik Light”.

In this regard, we would like to state that on Wednesday June 30, 2021, the subject expert committee (SEC) deliberated on the submission for Marketing Authorisation of Sputnik Light in India from Dr. Reddy’s Laboratories Limited (the Company). The Company presented to the SEC, interim safety and efficacy data from the Phase I/II clinical trial of Sputnik Light in Russia, along with a clinical trial protocol for a Phase III trial of Sputnik Light in India.

In view of the fact that (1) Sputnik Light is the first dose component of Sputnik V, and the Company has already generated safety and immunogenicity data on the first dose component in India through its clinical trial and; (2) a phase III efficacy trial is currently underway in Russian on Sputnik Light, the SEC recommended that:

  • The Company should submit safety, immunogenicity and efficacy data from the phase III clinical trial of Sputnik Light in Russia to the SEC for its consideration of Marketing Authorisation of Sputnik Light in India.

  • Further, the SEC also observed that in view of the safety and immunogenicity data already generated by the Company in India on the first dose component of Sputnik V (in other words, Sputnik Light), there seems to be inadequate data and justification in conducting a separate similar trial.

In this regard, we would like to state that such communications are in the ordinary course of the Company’s business and hence we do not have a practice of disclosing such communications.

The Company would further like to clarify that it has always complied with its reporting obligations under SEBI (LODR) Regulations, 2015, in a timely manner, and will continue to do so.

This is for your information and record.

With regards,

Digitally signed by SANDEEP PODDAR DN: c=IN, o=Personal, pseudonym=5baa65b04542ac0f9e3878c9d9 1f0db36d0548a0, 2.5.4.20=bfda99c592e4dc5b7a2e12970b950 5d6d51634ab609953e7b6cd73ea7af49394, postalCode=500084, st=TELANGANA, serialNumber=8185d5106ea0d6196f14ae66 0c09bac334f5ebc1a1790e158f29af33bf208c ac, cn=SANDEEP PODDAR Date: 2021.07.02 08:01:20 +05'30'

SANDEEP

PODDAR

Sandeep Poddar Company Secretary