The government has listened to the concerns expressed by biotech industry and the latest amendments incorporated in the Biological Diversity Act by Parliament in July 2023 is very for the industry, commented two experts, Dr Malathi Lakshmikumaran, top legal expert and partner in Lakshmikumaran & Associates, and Mr Ravi Bhola, Senior Partner, K&S Partners and secretary, ABLE.

They expressed these views while decoding the highlights of the newly amended biodiversity law at a webinar organized on this topic by ABLE on 25th August 2023. ABLE Chief Operating Officer, Mr Narayanan Suresh, recollected the 10-year long efforts of ABLE to highlight the need for these key amendments since 2013 to ensure smooth operations for companies in India to meaningfully commercialize the country’s vast biological resources.  ABLE President, Mr G S Krishnan, in his inaugural talk, mentioned the negative impact of some of the draconian provisions in the earlier Act that hindered investments by Indian and foreign companies.

Dr Malathi and Mr Ravi highlighted the 8 key amendments that will ease the way for doing biotech business in the country using natural resources.

These are:

1. Section 58 removed: offences are decriminalized
Violations under the Biological Diversity Act will now only attract stringent fines in most cases

2. Section 3(2) amended: More logical categorization of Indian and non-Indian entities under the Act now.
Earlier, there were vague definition that considered a company foreign even if there was a single foreign share holder, irrespective of the number of shares held.  Now, there will be a more liberal interpretation of the “foreign” character of a company. Only if the majority shareholders are foreigners or if foreign holder has influential voting rights or right to appoint majority of directors in an Indian company only will be treated as foreign entity.

3. Section 7 amended: More exceptions for Indian entities
a. Codified Traditional Knowledge
b. Cultivated Medicinal Plants and its products
c. AYUSH Practitioners

Mr Ravi Bhola explained that Indian companies can now do research on all these products and no prior permission from the National Biodiversity Authority (NBA) is needed. When any such effort is commercialized, the NBA only needs to be informed about it.

4. Section 2 amended: Expanded definition of Biological Resources introduced
The experts explained that the Act has brought the term “derivative. Derivative means a naturally occurring biochemical compound or metabolism of biological resources, even if it does not contain functional units of heredity.

For example, coal, a naturally occurring material has no specific genetic material in it and hence it is not a biological resource. On the other hand, azdirachtin, extracted from neem will be treated as a “derivate”.

5. Section 6 related to Patents amended
After the amendment, Indian entities do not need to take the NBA permission to file patent applications. This will lead to optimizing the work load at patent offices and reduce time to issue patents.

6. Section 59 amended: This means the biodiversity laws will not be applicable on Plant Varieties approved under the Plant Varieties Protection Act

7. Section 40 amended to expand the list of exemptions under the law
These include:

a. Items derived from normally traded commodities
b. Agricultural waste
c. Commercially grown medicinal plants

Due to this, various obligations under the Biodiversity law kicks in only when commercialization process starts. No permission required to do research

8. Section 55 amended: More penalties and appointment of adjudication officer
After removing prison terms, the law now prescribes a wide range of monetary fines to violators, ranging from Rs 1 lakh to Rs 50 lakh or event up to Rs 1 crore in exceptional cases for repeated offenders. There is also a provision to appoint an Adjudication officer with the powers of civil court to take up certain offences.

Overall, both the experts explained that thing will become easy now to use India’s biological resources.  The amendments have been approved by Parliament and will come into force when the Ministry of Environment and Forests officially notifies these changes in the original BD Act. Dr Malathi and Mr Ravi Bhola, answered a wide range of questions and provided clarifications to more than 100 members who tuned into the webinar.

Dr Malathi and Mr Ravi highlighted the 8 key amendments that will ease the way for doing biotech business in the country using natural resources.