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Knowledge and Expertise to enable Market Access through efficient Development and Approval Processes

The Indian chemical industry ranks the third largest in Asia and sixth in the world by output. It includes basic chemicals and their intermediates, petrochemicals, fertilisers, paints, pesticides, bulk drugs and pharmaceuticals, and is one of the most diversified industrial sectors, covering more than 70,000 commercial products.

In all, 15 Acts and 19 Rules have been laid down for chemical management. These can be classified into laws related to: Chemical imports and exports; Manufacturing of chemicals; Transportation of chemicals; Consumers’ use of chemicals; Protecting the environment and public health.

Multiple ministries formulate relevant acts and rules specific to their domain and multiple regulations currently govern different chemicals in India. For example, insecticides and pesticides have to be registered with the Central Insecticide Board and Registration Committee, by providing data related to the properties of the chemical and its effect on human health and the environment.

However, there is no such requirement for industrial or speciality chemicals. No umbrella regulation is in place that seeks to create an inventory of all the chemicals in commerce, or impose a mandate on the manufacturer of chemicals to provide hazard data to a central agency.

India’s national chemical policy has been pending since 2008, although a draft was published in 2014 for public comment, it still has not come into force. In early 2016, there were discussions about the need for a national chemical inventory, which would be critical for effective policy decisions. The first draft of the inventory was submitted to the DPCP listing almost 4,600 substances, although there were later revisions

Vyomus Consulting is a regulatory and development partner helping chemical companies commercialize products in India. From discovery to commercialization, we design and implement efficient and effective regulatory and product development solutions which integrate science, regulations and business objectives, to overcome product commercialisation challenges.

Our senior practitioners have a unique blend of business, science, regulations and technology expertise and include experts in product development, regulatory affairs, pharmacology, toxicology, preclinical and clinical trial design and evaluation, biostatistics, each with extensive product commercialisation experience.

Vyomus Consulting offers following services in this area :

Regulatory Consulting, Regulatory Strategy, Preclinical Study Approvals, Clinical Study Approvals, Market Authorisations, Labelling Services, Regulatory Submissions, Regulatory Reporting, Regulatory Intelligence, Authorised Agent Services.


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