Government News

The government of India made the Quick Response (QR) code mandatory on every bulk drug manufactured or imported in India to curb counterfeit or spurious quality of medicines. This rule will be applicable from 1st January 2023.

The QR code will help track and trace bulk drugs (Active pharmaceutical ingredients or APIs) during the entire supply chain. And it will ensure that the quality of APIs should not be altered.

​The Ministry of Health and Family Welfare includes Liquid Antiseptics for household use in schedule K after making an amendment in the Drugs Rules, 1945. Government had released draft notification with consultation with DTAB in September 2021. These rules may be called the Drugs 2nd Amendment Rules, 2022.

Indian Pharmacists will soon allow the sale of certain medicines without the prescription, as per new over the counter (OTC) policy for drugs. The Drugs Technical Advisory Board (DTAB)  has approved the new OTC policy and a draft notification will soon be issued by the health ministry.

Antiviral medicine molnupiravir which recently got approval from the CDSCO in India and is being manufactured by many pharma companies, has serious safety concerns, and thus has not been included in the national COVID-19 clinical protocol recommended by the health ministry, the Indian Council of Medical Research (ICMR) director general Balram Bhargava said.

Bhargava said the COVID-19 task force has debated twice whether to include the Molnupiravir in the COVID-19 treatment protocol but decided against it because of concerns.

Union Health Minister Dr Mansukh Mandaviya on Tuesday, 28 December, announced that the Central Drugs Standard Control Organisation (CDSCO) had approved two more COVID-19 vaccines and COVID-19 pill for restricted emergency use in India.

Two COVID-19 vaccines which are approved for restricted emergency use in India named Corbevax and Covovax. And Covid-19 pill from merck Molnupiravir is amongst the approved antiviral for COVID-19 in India.

The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of 20 formulations under Drugs (Prices Control) Order, 2013 based on the decision of 93rd Authority meeting dated 15.11.2021. The drug candidate Dapagliflozin and metformin extended release is included in 17 formulations out of 20 for which price fixation is applied. Dapagliflozin was patented by AstraZeneca and there are sixteen USA patents protecting this drug and one Paragraph IV challenge.

SARS-CoV-2 has affected more than 200 million people causing more than 5 million deaths worldwide as per the WHO statistics. The rise in mutant variants of SARS-CoV-2 virus has led to concerns regarding vaccine effectiveness. Delta (B.1.617.2) variant is the predominant strain in India. The vaccination programme in India is driven largely by the Covishield vaccine (ChAdOx1 nCoV-19).

The PLI Scheme for Pharmaceuticals is based on the strategy of Atmanirbhar Bharat- Strategies for enhancing Indias manufacturing capabilities and enhancing exports in ten sectors”, which had been approved by the Union Cabinet on 24.02.2021.  The Operational Guidelines for the scheme inviting applications from the pharmaceutical industry were issued on 01.06.2021 by the Department of Pharmaceuticals after intensive consultation with industry and related departments   and NITI Aayog.