Government announces waiver for several drugs approved from select countries

Government announces waiver for several drugs approved from select countries

Subject: Science and Tech

Sec: Health

Context:
In a decision that would make drugs manufactured outside India more accessible and affordable in the local market the Central government has decided to waive the requirement for clinical trials in India if the drugs are approved in the United States, United Kingdom, Japan, Australia, Canada, and European Union.

More on News:

• The Central Government has specified a set of five categories for new drugs that will be considered for the Indian market.
• Drugs including vaccines that fall in the category — orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, new drugs used for special defence purposes, and new drugs having significant therapeutic advances over the current standard care – will be considered under the waiver.
• India’s drug regulatory agency, Central Drugs Standard Control Organisation (CDSCO), the Central Government has authorised the exemption of local clinical trials for approval of new drugs, ‘as per Rule 101’.
• As per Rule 101 of New Drugs and Clinical Trial Rules, 2019 the Central Licensing Authority, with approval of the Central Government, may specify by an order, the name of the countries from time to time for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V of the said rules.
• The order has been a long standing demand of the pharmaceutical companies and health experts who have been advocating for enhanced drug accessibility for patients and for research.
• Anil Matai, director general, Organisation of Pharmaceutical Producers of India (OPPI) reacting to the announcement said that this a welcome and progressive move that will significantly benefit both domestic and foreign drug manufacturers by expediting the approval process and facilitating faster access to essential medications for Indian patients.
• The inclusion of specific categories such as orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, those for special defense purposes and new drugs with significant therapeutic advance over the current standard care would address critical and unmet medical needs.

CDSCO:

• The Central Drugs Standard Control Organisation (CDSCO)under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
• The New drugs and Clinical trials rules 2019 (New rules) was introduced on 19^thMarch 2019 by Government of India.
• New rules have set specific requirements for ethics committee (EC). The EC is required to follow requirements set as per New rules and to forward their report to Central Licensing Authority (CLA).
• The new rules define orphan drugs – for the first time – as drugs to treat conditions affecting less than 500,000 people in India.
• As per the new rules, Indian regulators have now been empowered to exempt orphan drugs from Phase III and IV clinical trials.
• On 13 January 2021, the Government of India introduced a Comprehensive ‘National Policy For Rare Diseases 2021’ (which included – Research & development to manufacture orphan drugs, treatment of rare diseases, etc.), replacing its ‘National Policy for Treatment of Rare Diseases 2017’.

Rule 101 of CDSCO:

• Rule 101 allows the Drugs Controller General of India (DCGI) to specify certain countries for considering waiver of local clinical trials for approval of new drugs.

An Orphan Drug:

• An Orphan Drug is a medicine or other medical product used to diagnose, prevent, and treat a life-threatening chronic condition or disorder.
• It is called an ‘orphan drug’ because of its limited market (which is rare, with about 450 rare diseases recorded in India so far), and is unlikely to be adopted by a pharmaceutical company.
• By selling only to a small group of patients, a drug manufacturer will likely not be able to recover the development and marketing costs, so the Government of India has implemented a new ‘National Policy for Rare Diseases (NPRD)’ in the year 2021 to encourage the production of these Orphan drugs.