Industry Updates & Events

July 28, 2021

Govt announces Rs 50,000 crore loan guarantee scheme for health infrastructure

To boost the health infrastructure in tier-2 and tier-3 cities, government had announced a coverage of Rs 50,000 crore along with Rs 23,220 crore specially for paediatric care.
This scheme would provide coverage of 75% for new projects and 50% for project in expansion with maximum loan up to Rs 100 crore for 3 years at 7.95%.

August 27, 2021

Anthem Bioscience launches the company’s first similar biologics ‘InsuTrend’ in India

DCGI granted Marketing authorisation for similar biologics ‘InsuTrend’ (human insulin) manufactured by Anthem Biosciences on August 27, 2021.
InsuTrend is a similar biologic of Eli Lilly’s Humulin (insulin human rDNA) and Novo Nordisk’s human insulin.

July 30, 2021

Indian Certification for Medical Devices (ICMED) Scheme

The Scheme is intended to enhance patient safety, and provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers.
This move is also intended to significantly eliminate trading of sub-standard products or devices of doubtful origins, a widespread and injurious phenomenon in the Indian market.

July 12, 2021

New monograph on a single-source anti-TNF-alpha monoclonal antibody released for public consultation in Pharmeuropa

A new draft monograph, Golimumab concentrated solution (3103), has been published in issue of Pharmeuropa (33.3), the European Pharmacopoeia (Ph. Eur.) online forum for comment.
The new draft monograph has been elaborated using the single-source approach and reflects the considerations outlined in the EDQM’s scientific publication on Elaborating European Pharmacopoeia monographs for biotherapeutic proteins using substances from a single source.
The deadline for comments is 30 September 2021

July 1, 2021

Zydus applies to the DCGI for EUA to launch ZyCoV-D, the world’s first Plasmid DNA vaccine for COVID-19

Zydus Cadila has requested emergency use approval for its ZyCoV-D three-dose Covid shot that is the world’s first Plasmid DNA vaccine.
Zydus claims its vaccine is 66.6 per cent effective against symptomatic Covid cases and 100 per cent for moderate disease.

May 29, 2021

Bharat Biotech needs to give phase-3 efficacy data for WHO nod

Bharat Biotech said its emergency use listing (EUL) application had been submitted to WHO, Geneva, and regulatory approvals are expected between July and September.
Bharat Biotech will have to submit phase 3 clinical trial efficacy data of Covaxin before the decision.

June 29, 2021

Pharma Majors Collaborate for Clinical Trial of Investigational Oral Anti-Viral Drug Molnupiravir for COVID-19

Torrent Pharma has collaborated with Cipla, Dr. Reddy’s, Emcure and Sun Pharma for clinical trials of investigational oral anti-viral drug Molnupiravir for the treatment of mild COVID-19 in an outpatient setting in India.
According to SEC of CDSCO, Dr. Reddy’s will conduct the clinical trial using its product, and the other four pharma companies will be required to demonstrate equivalence of their product to the product used by Dr. Reddy’s in its clinical trial.

May 18, 2021

Quebec Announces Intention to Implement a Biosimilar Switching Policy

Quebec becomes the fourth province to implement a biosimilar switching policy under its public prescription drug insurance plan.

August 20, 2021

Zydus receives EUA from DCGI for ZyCoV-D, the only needle-free COVID vaccine in the world

Zydus Cadila received approval on first plasmid DNA vaccine ZyCoV-D by Drug Controller General of India (DCGI) under Emergency Use Authorization (EUA) scheme.
It is a three dose vaccine which got approved for pediatric population (>12 years).

July 27, 2021

Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry

The USFDA had issued a final guidance to assist sponsors in using alternate electronic formats for submitting applications that are exempt from electronic common technical document (eCTD) filing requirements.
This guidance will be applied to new drug applications (NDA), abbreviated new drug applications (ANDA), as well as to certain drug master files (DMF), biologics license applications (BLA) and investigational new drug applications (IND) submitted to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research (CDER & CBER).

July 27, 2021

Continuous Manufacturing of Drug Substances and Drug Products Q13- Currently under public consultation

This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM).
Three different models of continuous manufacturing has been described in the draft guideline: one includes a combination of approaches in which some unit operations operate in a batch mode while others operate in a continuous mode; the second is where all unit operations of a drug substance or drug product manufacturing processes are integrated and operate in a continuous mode; and the third is an approach in which the drug substance and drug product unit operations are integrated across the boundary between drug substance and drug product to form a single continuous manufacturing process.

July 5, 2021

Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry

The USFDA had issued a final guidance to assist sponsors in using alternate electronic formats for submitting applications that are exempt from electronic common technical document (eCTD) filing requirements.
This guidance will be applied to new drug applications, abbreviated new drug applications, as well as to certain drug master files, biologics license applications and investigational new drug applications submitted to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.

May 8, 2021

DCGI approves anti-COVID drug developed by DRDO for emergency use

India’s regulator has approved a new, oral Covid-19 drug that promises to reduce hospitalisation time and oxygen dependency.
The 2-deoxy-D-glucose (2-DG) drug developed by the Defence Research and Development Organisation has proved to be effective in three phases of trials on Covid-19 patients.
It is approved under EUA scheme.

June 22, 2021

AstraZeneca Covid vaccine linked to rare neurological disorder in India, UK

Indian and England patients which received AstraZeneca-Oxford Covid-19 vaccine had developed a rare neurological disorder called Guillain-Barre syndrome, reported in two separate studies.
In Guillain-Barre syndrome (GBS), the body's immune system mistakenly attacks part of its peripheral nervous system --the network of nerves located outside of the brain and spinal cord.

June 7, 2021

Pharmaceutical officials propose new USP harmonized chapter on visual inspections

Pharmaceutical industry officials have proposed the United States Pharmacopeia develop a new harmonized chapter on visual inspections of parenteral drugs that would address current testing gaps.
They recommend a harmonized compendial chapter which includes use of “universally available standards” to train inspectors, qualify the methods, and validate the results.

August 27, 2021

Three back-to-back biosimilar from Enzene Biosciences got approval by DCGI (India)

Drug Controller General of India (DCGI) granted three back to back Marketing Authorisation for biosimilar manufactured by Enzene Biosciences.
The first biosimilar Teriparatide which got approved on February 04, 2021, for treating Osteoporosis. Learn More
The second biosimilar Romiplostim which got approved on August 20, 2021, for treating Immune thrombocytopenic purpura (ITP). Learn More
The third biosimilar Denosumab which got approved on August 27, 2021, for treating Postmenopausal osteoporosis. Learn More

August 1, 2021

New collaboration project of the Access Consortium for the approval of biosimilars

The Access Consortium is a joint initiative of like-minded, medium-sized regulators (TGA, BRDD, HSA, Swissmedic, MHRA).
Approval of several drugs was successful in New Active Substance Work Sharing Initiative (NASWSI).
New initiative has been taken titled ‘Biosimilar Medicine Work Sharing Initiative (BSWSI)’.
Companies that submit a registration application for biosimilars in at least two member countries of the Access Consortium are now entitled to a pilot project in which the authorities coordinate their assessment.

July 15, 2021

Recommendation- How to Evaluate and Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management, PI 054-1

This document addresses two fundamental and inter-related elements of the PIC/S GMP Guide - PQS effectiveness and the management of changes.
It provides practical guidance for GMP Inspectors, and its implementation could lead to the timelier management of risks to product quality and patient safety, better quality and manufacturing performance, continual improvement and innovation.
In addition to providing guidance for GMP Inspectors, the document provides the pharmaceutical industry with a ready-made solution for addressing a key aspect of ICH Q12 - the requirement to have an effective PQS that can support the risk-based management of post-approval changes when there is more flexible regulatory oversight of such changes in place.

July 6, 2021

Cipla enters into licensing pact with Eli Lilly for Baricitinib drug

Cipla signed a royalty-free, non-exclusive voluntary licensing agreement with US' Eli Lilly for the manufacture and commercialization of the drug Baricitinib for Covid-19 indication.
Baricitinib was issued a restricted emergency use approval.

May 25, 2021

Roche’s Antibody Cocktail launched in India at Rs 59,750/dose

Roche India and Cipla launch Roche’s Antibody Cocktail (Casirivimab and Imdevimab) in India priced at Rs 59,750 per dose for the treatment of mild to moderate COVID-19 patients.
It is approved under EUA in India

June 29, 2021

Moderna becomes 4th COVID-19 vaccine to get approval for use in India: Reports

Cipla received Drugs Controller General of India's (DCGI) nod to import Moderna's COVID-19 vaccine for restricted emergency use.
The vaccine has been shown to be around 94% effective against COVID-19.

June 29, 2021

Europe Union’s new move may hit India, South Africa’s patent waiver plan

European Union has drawn up a counter proposal which could ``undermine’’ India and South Africa’s proposed submission at the World Trade Organization seeking a waiver on intellectual property (IP) on Covid-19 drugs and vaccines.
If adopted at the WTO, the waiver would provide countries with critical policy space to address IP barriers to increase collaboration in research and development, manufacturing, scale-up, and hence boost supply of Covid-19 medicines and vaccines.
The EU proposal calls governments to ``facilitate the use of compulsory licensing within the WTO’s existing agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).