Mutual Benefit Agreement (MBA)

Background Query

Many BioPesticide companies have submitted application for Export Regn of BioPesticides. Same objection is coming for all such applications.
VS BASAI: Can we have a look at the nature of deficiencies and how it’s being articulated for understanding it further.

One question though, since when has been PMFAI been considered to represent the biological agri-input companies?

Suggestive presentation outline

India is emerging as great resource country for BioPesticides.

Our PM envisions Make in India.

We have very good National Biodiversity Law and NBA

We have State BioDiversity Boards for Access Benefit Sharing Agreement. (ABS)

VS BASAI: What is the GOI approach on this particular aspect. Though, we know that India is a MAD signatory (Mutual Acceptance of Data). Then again ONLY for toxicological data.

We have two Depositories for Microbes under Budapest Treaty

Thus Indian Companies can offer 100% Legal Microbes global market.

VS BASAI: Are we aware of the fact that there is a multi-ministerial committee looking into the Import of such products in our country. So, what’s the position of other countries in this regard.

CIB&RC has to facilitate such exports
CIB&RC raising issues of MBA- is not relevant for granting Export Registration or BioPesticides

VS BASAI: Do we have a justification for the same along with appropriate supporting documentation.

We must impress this well
MBA (Mutual Benefits Agreement) is multilateral agreement issue among likeminded Governments.

BASAI: This indicates that it is actually a G2G approach and may not be sorted at the level of the Sect. CIB&RC or the RC in particular.

We as industry has no role to play.

Our BIPA President Dr KRK Reddy has asked – who will take lead in making PPT?
Dr Dhingra has sent his views on a draft PPT – Thanks Dr Dhingra.
I invite all stakeholders to react quickly
I volunteer to make draft PPT for approval of all Associations and I can present the same on 4th October 2019.

VS BASAI: The issue is complex and has to be understood in the true sense to represent the same. A debate is required to understand the issue. As indicated above, it would be worthwhile to understand ‘the nature of deficiencies and how it’s being articulated for understanding it further’.

Looking into the time constraint and lack of understanding amongst the most of us, it is suggestive to ask for the presentation to be postponed and presented in the Nov. 2019 RC.

It is suggestive that a select few stakeholders across the concerned industry may sit together and debate upon the subject to raise a consensus.

Since this decision for inviting for a presentation was notified in the 397 RC dated 30.01.19 & 4.02.19 which was as stated:

4.0 Export Cases
4.1 List under section 9(3) Export applications The Agenda was deliberated in detail & approved the cases as per Annexure 4.1.1, 4.1.2, 4.1.3, 4.1.4& 4.1.5. The Committee further decided that the applicants of import for export category shall be subjected to the decision taken by the Committee in its 357th meeting. RC decided following:-

1. Random cross verification of companies should be taken up by DPPQ&S.
2. Sectt. of CIB&RC to re-visit earlier decision of RC in light of above where import for export cases had been brought.
3. Bio-pesticide association may be called for making a presentation on the export of bio- pesticides with the emphasis on mutual benefit agreement (MBA) with importing country.

The question remains

“Why were we sitting on the issue at hand since Feb. 2019 i.e approx. 7 months since the decision was taken???”

And if debated, what was the plan all along! And Who all debated the issue?

Some interesting information relevant excerpts to the subject that may be considered prior to any presentation to take place:

Quality Standards

Government is committed to transforming India into a manufacturing and exporting hub. This will require focus on improving product quality. Many Indian products fail quality tests due to traces of pesticides, pathogens, illegal dyes, etc. An endeavour would be made to upgrade quality and infrastructure to help firms to move to higher quality standards and also protect Indian consumers from substandard imports. Setting up more globally accredited testing laboratories, enhancing the capacity of Indian testing laboratories and Mutual Recognition Agreements (MRA) with partner countries would be areas of focus.

A roadmap has been developed on measures required to protect consumers, raise the quality of the merchandise produced and enhance India’s capacity to export to even the most discerning
markets. Standards Conclaves are being held annually in New Delhi and various regions to build awareness on the need for producing quality products in the country. A long term branding strategy has been conceptualised and is under implementation to enable India to hold its own in a highly competitive global environment and to ensure that ‘Brand India’ becomes synonymous with high quality.

Further, a programme to promote the branding and commercialisation of products registered as Geographical Indications and facilitate their exports has been initiated.

What India should do to be more participative in Global Value Chain (GVC)?

India needs to improve connectivity infrastructure and industrial laws to raise its ranking in world trade. Policy initiative must target all parts of the GVC life-cycle from conceptualisation, development of a prototype, to manufacturing, to after-sales service. India needs to set up a National Trade Network (NTN) to enable all export-import related compliance online. NTN will allow exporters to file all documents online at one place; there will be no need to deal with customs, shipping companies, sea and airports, and banks separately. Automate port and customs operations and allow green channel clearances (clearance of goods without routine examination of goods) for most consignments. India needs to match the turnaround time of the ships with the global best parameters. This will ensure quicker transactions and allow better use of infrastructure. Indian firms need to upgrade production processes and product quality to meet the requirements of GVCs. India needs to create an institution to develop standards, set up globally accredited testing laboratories, and sign Mutual Recognition Agreements (MRA) with partner countries. We need to identify sectors with higher value addition as well as low entry barriers in global markets, to achieve quicker export success.

These steps will reduce the cost and time of exporting and increase competitiveness (refer Annex 1)

Case study:

The Mutual Recognition Agreement (MRA) between FDA and European Union allows drug inspectors to rely upon information from drug inspections conducted within each other’s borders. Under the Food and Drug Administration Safety and Innovation Act, enacted in 2012, FDA has the authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if the FDA determined those authorities are capable of conducting inspections that met U.S. requirements. FDA and the EU have collaborated since May 2014 to evaluate the way they each inspect drug manufacturers and assess the risk and benefits of mutual recognition of drug inspections.

Benefits of MRA:

Yields greater efficiencies for U.S. and E.U. regulatory systems by avoiding duplication of inspections,

Enables reallocation of resources towards inspection of drug manufacturing facilities with potentially higher public health risks across the globe,

FDA will continue to perform some inspections in EU countries with capable inspectorates, such as product manufacturing assessment inspections to support marketing approval decisions. However, FDA expects to perform fewer routine surveillance inspections in EU countries with a capable inspectorate.

FDA is collaborating with the following inspectorates it has assessed as capable and is reviewing their recent inspection reports and related information in determining each manufacturer’s suitability for the U.S. market in lieu of an FDA site inspection. FDA expects to complete its capability assessment of all EU inspectorates by July 2019.

A Confidentiality Commitment (CC) is a document that sets up the legal framework for FDA to share certain kinds of non-public information with FDA counterparts in foreign countries and international organizations as part of cooperative law enforcement or regulatory activities.

VS BASAI: India does not have a Confidential Business Information legislation in place

A CC must be in place in order for FDA to share non-public information with a counterpart, but a CC never requires FDA (or its counterpart) to share information.

A Cooperative Arrangement is a written understanding that FDA can establish with one or more foreign governments or international partners that describes the willingness and good-faith intentions of FDA and its counterpart(s) to engage in cooperative activities. Cooperative Arrangements can have a variety of titles, including “Memorandum of Understanding.”

Even with a Cooperative Arrangement in place, the FDA cannot share non-public information unless a Confidentiality Commitment exists.

VS BASAI: Trust the above information shared will bring in a perspective to the issue at hand whilst emphasis on mutual benefit agreement (MBA) with importing country is proposed. This is a Ministry of Commerce issue under the DGFT & Department for Promotion of Industry & Internal Trade (DPIIR, Director General Trade Restrictions (DGTR) and other obligations under the WTO and relatively relevant treaties India is a signatory to and not a signatory to, need be understood.

Note: Placed in for information.
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