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CHAI wants AP SBB to exempt Ayurveda drug makers from applying for NoCs for using biological resources
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Peethaambaran Kunnathoor, Chennai
May 14 , 2024
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In response to the letters written to the ayurvedic drug manufacturers by the Andhra Pradesh State Biodiversity Board (AP SBB) asking them to obtain NoCs from the SBB for utilization of biological resources, the Confederation of Herbal and Ayurvedic Industries (CHAI) in the state has informed the Board that they are neither seeking access to biological resources nor collecting them, but only purchasing raw drugs for the codified formulae to make the drugs.
CHAI has wanted the Board to exempt the traditional drug makers from applying for NoCs and from remitting the prescribed fees as their members are micro and small level drug makers dealing in classical formulae.
The SSB has asked the industries that they should seek the approval of the Board in Form 1 Application along with Rs. 10,000 towards fee as per Rule 16 of the AP Biological Diversity Rules 2009, within 15 days of receipt of the letter.
According to Dr Vemula Bhanuprakash, general secretary of the confederation, as per the Biological Diversity Act, 2002, the drug manufacturers are liable to intimate the biodiversity board about the use of resources, but there is no need of obtaining any prior approval from the Board. He said his association has sent one legal notice to the member-secretary of the Board wanting him to exempt the codified traditional drug makers (manufacture based on classical texts) from applying for NoCs by remitting a fee of Rs. 10,000. He further said the association is now contemplating approaching the court against the notice and the physical visit of SBB officers along with forest officials in industrial units insisting for NoCs.
To his clarification, Dr Vemula has quoted Section 7 of the principal act and the amended rule of 2009. “No person, other than the person covered under sub-section (2) of Section 3, shall access any biological resource and its associated knowledge for commercial utilisation, without giving prior intimation to the concerned State Biodiversity Board, but such access shall be subject to the provisions of clause (b) of Section 23 and sub-section (2) of Section 24, provided that the provisions of this section shall not apply to the codified traditional knowledge, cultivated medicinal plants and its products, local people and communities of the area, including growers and cultivators of biodiversity and to ‘vaidyas’, ‘hakims’ and registered Ayush practitioners only who have been practicing indigenous medicines including Indian systems of medicine as profession for sustenance and livelihood.” He said the AP SBB’s letter demanding for obtaining their NoC is against the provisions of the principal act.
Giving further clarification, Dr Vemula said the codified knowledge/formulae means that they are manufacturing the drugs as per the classical texts, for which they are entitled to use the biological resources. But it is necessary to intimate the biodiversity board about what kinds of resources they are using for the formulations. According to him, the manufacturers are ready to follow and comply with the provisions of the principal act, and wanted the SBB to exempt them from remitting Rs. 10,000.
Section 7 of the Biological Diversity Act, 2002, says that no person who is a citizen of India or a body corporate, association or organisation which is registered in India, shall obtain any biological resource for commercial utilization, or bio-survey and bio-utilization for commercial utilization except after giving prior intimation to the SBB concerned.
Whereas, Rule 16 (1) of the AP Biodiversity Rules 2009 says that any person seeking access to/collection of biological resources and associated knowledge for research or for commercial utilization shall be accompanied by a fee of Rs. 1,000 in case such access is for research purpose, and Rs.10,000 for commercial utilization, and shall be in the form of a cheque or demand draft. Penal provisions are prescribed under Act in case of non-compliance or violation of the provisions of different sections under the Act.
“According to the Government of India’s Biological Diversity Amendment Act 2023, the ayurvedic industry has been exempted from the Act. The Section dealing with penal action has also been omitted. So, we would like to inform about the notice of the AP SBB to the attention of the National Biodiversity Board and Ministry of Law and Justice, Government of India,” he told Pharmabiz.
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