News about Regulation

DCC Backs Inclusion of Good Distribution Practices in Drugs Rules, 1945

Recognizing this as a potential risk to drug quality and patient safety, the committee recommended revising the guidelines in line with WHO standards, giving them legal backing by incorporating them into the Drugs Rules.

Regulation | 30/06/2025 | By Darshana |  417

DCC Agrees with DTAB Proposal to Fix QR Codes on Vaccines, Antimicrobials, Anticancer and NDPS Drugs

The Drugs Consultative Committee (DCC) has asked the pharma industry to raise public awareness regarding the use of Quick-Response code, while dismissing concerns raised by some stakeholders that the usage of QR codes for scanning by the public is dismal, as not substantial in public interest.

Regulation | 27/06/2025 | By Darshana |  195

CDSCO Eases Licensing Norms for Outsourced Sterilisation of Medical Devices

The move addresses longstanding concerns from industry stakeholders about the need for a separate loan license under the Medical Devices Rules (MDR), 2017, when outsourcing sterilisation to another licensed facility.

Regulation | 26/06/2025 | By Darshana |  262

Chhattisgarh's Pharmacy Education Faces Industrial Gap Despite Talent Pool; Experts Call for Urgent Pharma Infrastructure Push

Further, this absence directly impacts both the students’ and teachers’ abilities to contribute for manufacturing sector, according to Prof. Shekhar Varma, former registrar of Chhattisgarh State Pharmacy Council and professor of pharmaceutical sciences at the Central University in Bilaspur.

Regulation | 24/06/2025 | By Darshana |  147

Novartis Announces Expiration of HSR Waiting Period of Regulus Therapeutics Tender Offer

Novartis announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the HSR Act), in connection with Novartis’ previously announced tender offer to acquire all of the outstanding shares of common stock.

Regulation | 24/06/2025 | By Darshana |  116

DGTR Schedules Oral Hearing in Anti-Dumping Probe on Chianese MIPA Imports

The investigation, initiated on December 30, 2024, aims to determine whether Chinese MIPA imports are being unfairly priced and whether they are causing material injury to the Indian industry. MIPA is a key chemical used in the production of active pharmaceutical ingredients (APIs) and drug formulations.

Regulation | 24/06/2025 | By Darshana

Govt Opens Export Quota for Pharma Grade Sugar with Strict Quality and Compliance Norms

Only eligible pharmaceutical exporters can apply for this quota between June 20 and July 20, 2025, exclusively through the DGFT’s online portal under “Non-SCOMET Restricted Items.” No physical applications will be accepted, and each IEC (Importer Exporter Code) holder is allowed to submit just one application, ensuring fair and transparent allocation.

Regulation | 19/06/2025 | By Darshana |  146

DoP extends timeline to apply for 11 bulk drugs under PLI scheme

The DoP invited applications from eligible manufacturers under the scheme on May 14, for products which have not been applied for or are partially produced under the scheme, by the industry.<br />

Regulation | 18/06/2025 | By Darshana |  244

MEDITECH STACKATHON 2024 Launched to Propel India's MedTech Sector Towards Innovation

Dr. Chawla emphasized the immense potential of India's MedTech industry, projecting a growth rate of 28 percent annually, with estimates indicating a market size of USD 50 billion by 2030.

Regulation | 08/05/2024 | By Abha |  906

Government Unveils Upgraded Pharmaceuticals Scheme to Boost Industry Standards

The revised scheme, a significant step in the government's efforts, follows a comprehensive review by the Scheme Steering Committee.

Regulation | 12/03/2024 | By Abha |  801