The Ministry of Environment, Forest and Climate Change has recently been in the news for instating an interim measure that exempts manufacturers of bulk drugs and intermediates from the Environment Impact Assessment (EIA) up until 30th September. The objective behind this exemption is to facilitate rapid clearances for manufacturers and intermediaries involved in the production of Covid-19 related medications.
Understanding The Environment Impact Assessment
The Environment Impact Assessment (EIA) is a procedural tool used to assess the probable environmental ramifications of a proposed development project. This assessment takes into consideration the interplay of socio-economic, cultural, and health impacts – both positive and negative.
The United Nations Environment Programme (UNEP) puts forth that EIA serves to identify the environmental, social, and economic outcomes of a project prior to decision-making. The primary goal is to forecast environmental effects at the initial stage of project planning and design. It also aims to discover methods to mitigate adverse impacts, mould projects to fit the local environment, and present the predictions and alternatives to decision-makers.
In India, the EIA is supported by the statutory provisions of the Environment Protection Act, 1986 which includes an array of provisions regarding its methodology and procedure.
The Specifics of the Exemption
As per the recent exemption, all proposals for projects or activities relating to Active Pharmaceutical Ingredients (API, also known as Bulk Drugs), received up until 30th September 2020, will be treated as Category B2 projects. However, any subsequent amendment or expansion or change in product mix after the mentioned date will be regarded in accordance with the provisions in force at that time.
Under the Environment Protection Act, 1986, projects are classified into three categories – Category A projects are appraised by the Union Ministry, Category B projects are evaluated by the states, and Category B2 Projects are exempted from EIA and public hearings.
Impact on Drug Production Amid Covid-19
This exemption is expected to ensure the steady production and availability of drugs required for tacking the Novel CoronaVirus. As part of a comprehensive strategy to manage the outbreak, it is crucial that the manufacturing process of these drugs does not hit any regulatory roadblocks.
Situating Active Pharmaceutical Ingredients
Active Pharmaceutical Ingredients are crucial to the manufacturing process of drugs. The Hubei province of China is a major player in the API manufacturing industry. India, on the other hand, relies heavily on imports of APIs from China.
To mitigate this dependency, the Union Cabinet recently approved two schemes – the scheme on Promotion of Bulk Drug Parks and the Production Linked Incentive (PLI) Scheme. These initiatives are designed to encourage domestic manufacturing of critical Key Starting Materials/Drug Intermediates and Active Pharmaceutical Ingredients in the country.
