Regulatory & Legal

Regulatory and LegalDevelopment of any sector needs positive policy environment and enabling provisions. The medicinal plant sector will also get boost if the concern provisions are put in place. The earliest Acts and policies of Indian Government are basically conducive to the growth of the MPs as the classification of forests into various categories. The limiting of the rights of the people in the forest lands did help the conservation of the MPs indirectly, the Panchayati Van Adhiniyam is subjected to many Central and State Acts, policies. The people are largely unaware of the Government endeavours and the impact of various existing Acts, Rules, Policies and orders of the Hon’ble Courts, these needs to be explained for the proper participation of the public in Forest Management. The herbal sector in the State is governed under various sets of legislations related to management, harvest, transit, cultivation and trade of the medicinal plants. Most of these legislations are more of a means to control illegal harvest and trade than to facilitate development of this sector. Preventive legislation as against an enabling one. In wake of this multiplicity of the legal and administrative provisions related to the sector, there is a need to examine, amend, revise, and modify the current/existing legislation and guidelines which are governing this sector and propose a uniform appropriate legislation based on the basic principle of conservation, sustainable harvest and utilization of resources in the state.

Some important International/National Acts, Rules, Conventions, Notifications, Obligations, etc. on Medicinal Plants.

1927 Indian Forest Act, 1927
1933 Panchayat Raj Act, 1933
1955 The West Bengal Forest Produce Transit Rules, 1955
1966 Andaman and Nicobar Island Forest Produce Transit Rules, 1966
1972 Wildlife (Protection) Act, 1972 (Amended 2003) Also 2006
1975 The Convention on International Trade in Endangered Species of Wild Fauna and Flora, 1975
1975 Kerala Forest Produce Transit Rules, 1975
1980 The Forest (Conservation) Act (Amended), 1980
1986 Environment Protection Act, 1986
1988 National Forest Policy, 1988
1994 Negative list of Plants for Exports and Imports (Revised), 1994
1996 Panchayat (Extension to Scheduled Areas) Act, 1996
2000 Formation of National Medicinal Plants Board, 2000
2002 National Biodiversity Strategy and Action Plan, 2002
2002 The Biological Diversity Act, 2002
2004 Biological Diversity Rules, 2004
2004 Negative list of MAP Collection from Wild, 2004
2006 Scheduled Tribes & Other Traditional Forest Dwellers Act, 2006
2014 Maharashtra Forests Rules, 2014
2013 The HP Forest Produce Transit (Land Route) Rules, 2013
2015 Export Import Policy, 2015-20
2017-31 National Wildlife Action Plan 2017-31

Plants have been used in traditional medicines for centuries and hence cannot be protected by patent. They can be registered as individual geographical indications or regional trademarks, with explicit rules of origin. The introduction of new herbs to markets is often very difficult and needs appropriate scientific documentation. Intellectual property rights are an issue of potentially major importance to all developing country exporters. Protecting traditional and ethno medicine/folk medicine is very important.

Great awareness is required for monitoring the complex and increasingly stringent health and safety regulatory requirements. Traceability studies, information on the origin and the quality of raw material, is of utmost importance. Products can only be marketed if the steady quality of the raw material can be ensured.

Points to be considered are:

  • Making proper provisions for protecting IPR on Indian MPs.
  • Indian Certification standards such as Organic and Fair Trade should be developed for the MPs sector and encouraged;
  • Classical medicines mentioned in text books should be prescribed and dispensed in government hospitals & clinics and covered under health insurance for reimbursement.
  • A supporting mechanism should be established to amend periodically important Acts and their rules (Negative list, RET list etc.) taking into consideration the latest trends in collection & cultivation of MPs.
  • A workable system should be in place to communicate with international regulatory bodies (CITES, UNDP etc.) and updating about the latest development, particularly in the aspects of cultivation and collection of regulated MPs to encourage India’s export.There is need to establish a clear, simple and transparent mechanism of regulation such as permits for cultivation, harvest, marketing, transport and export for key species in trade. Standardised formats for all levels of permissions required, such as from DFO to CWLW may be prescribed, along with when they should be applied and also timelines for issue, for reasons of simplicity and establishing authenticity.
  • National Forest Policy should take care of economic up-liftment of marginal farmers and local tribals dependent on MPs for their livelihood. Creation of database of Minor Forest Produce(MFP) will help in marketing, reforestation and conservation of MPs;
  • MPs produce from cultivation source should be notified as ‘Agriculture Produce’ to promote cultivation and trade;
  • Set up State level Cultivators’ Commission with representation of cultivators for ensuring dynamic government response to cultivators’ problems;
  • Taxation relief to industry using cultivated raw materials; introduce a policy for scaled up incentives on the basis of primary, secondary and tertiary level value addition as also establishing a clear chain of custody. That will also encourage “Make in India” , as also address Item xii below. Promote an e-commerce platform for encouraging direct trade in such produce
  • Appropriate guidelines should be laid down to protect ‘Contract Farming’ for promotion of cultivation of MPs. It is an effective tool for sustainable supply with assured price of MPs to industry and thereby conservation. Overseas organisations cultivating MPs in Contract Farming module successfully like that in France & other European countries should be encouraged to replicate their module as per Indian conditions. It will benefit Indian cultivators enabling them to adopt latest technology and management techniques;
  • Suitable guidelines for importing quality seeds, seedlings and other planting material of MPs should be favourable for Indian cultivators so that they are able to take up the cultivation;
  • Favourable regulatory environment should be created for the foreign industries like cosmeceuticals, nutraceuticals, phytopharmaceuticals etc. that helps them to take up production;
  • Available HS Code may be extended by further sub division or add digits to include the Indian MPs under appropriate sub headings to maintain perfect database;
  • A dedicated working group with representation of all stakeholders for import and export of MPs should be constituted to advise in drafting of Export-Import Policy;
  • Single window clearance of export and import of MPs will help in promoting the trade; Add a specialised Scientific research Institution in the list of CITES Scientific Authorities. Also see if any agency can be added as a Management Authority under CITES.
  • Registration of collectors, cultivators and traders may be made obligatory; Develop standardized protocols for registration. What is the incentive for registration and disincentive for not registering? That only will make this work. Registration for the sake of registration will only add another layer of bureaucratic working.
  • Import duties may be rationalised to protect cultivator if same is under cultivation in India;
  • Reexamine the provisions related to Schedule VI of the WLPA and see how it can be reworked to the advantage of encouraging sustainable trade in selected species.
  • Maybe set up a National Mission to achieve a set of goals in a time bound manner in this sector.
  • Wide dissemination of the above, preferably in regional languages also, to ensure wider reach and acceptability.