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Industry sees regulatory processes attaining global standards with CDSCO, MHRA pact

Nandita Vijay, Bengaluru
Monday, November 9, 2020, 08:00 Hrs  [IST]

Indian pharma industry is upbeat about the pact between the Central Drugs Standard Control Organisation (CDSCO) and the UK Medicines and Health Products Regulatory Agency (MHRA) for cooperation and exchange of information related to medicines and medical devices.

According to the industry, this pact will ensure that regulatory processes are of global standards and will strengthen ties between companies of the two countries in the development of COVID-19 vaccine, medicines and devices during the ongoing pandemic.

With the ongoing pandemic leading to fast tracking approvals of medicines and medical devices, the MoU seeks to strengthen the two regulatory bodies for Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Distribution Practices and Good Pharmacovigilance Practices (GpvP) come to the fore.

According to Dr Viranchi Shah, senior vice president, IDMA, India plays an important role as a global pharmacy. Signing of MoU between CDSCO and UK MHRA reflects that we are a strategic partner to UK for their pharma and devices supply chain. IDMA welcomes this development and shall continue to work closely with the government and CDSCO, and in helping Indian companies access the UK markets.

The pact focuses on bolstering trade ties and capacity building to scale up production of medicines and medical devices, and encourage scientific conferences between India and the UK. Working in an increasingly global environment, the sharing of intelligence on medicines and medical devices would reinforce good practices internationally, and identify emerging safety trends to protect public health.

This is the beginning of a new era where India is getting closure to global regulatory bodies. The MoU with MHRA is the step in the right direction by CDSCO. The sharing of best practices in GMP, GLP and GVP will help India to strengthen its regulatory systems meeting global standards as well as support in exports. In the coming decade, we can visualize harmonization of regulatory guidelines to some extent and MHRA will start accepting CDSCO approvals for granting MHRA certification to Indian companies. This collaboration will also support India to be part of PIC/S and ICH which is a long-standing wish list of Industry, said Kaushik Desai, a pharma consultant.

Suresh Khanna, designated partner, Dossier Solutions and Services LLP, noted that this was indeed a very bold decision and will be very helpful to CDSCO to keep abreast with latest developments internationally in regulatory domain. This is one step towards harmonization of regulatory practices followed by CDSCO and UK MHRA which will be very beneficial in the long run to the Indian pharma industry and other stake holders in the areas of pharma services.


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