Fwd: Inputs on Product Specific Rules (PSRs) ROO - reg.

[Rajat Kapoor (ADMI-Secretariat)]

Dear Members,

Greetings from the Association of Diagnostics Manufacturers of India (ADMI).

The Department of Pharmaceuticals (DoP) has sought inputs/comments from industry stakeholders on the proposed Product Specific Rules (PSRs) under Rules of Origin (RoO) in the context of recently concluded Free Trade Agreements (FTAs).

For the medical devices sector, the Department has proposed the following PSR recommendations:

• Six-digit HSN code change OR 35–40% value addition
• Value addition not to exceed 45% during negotiations
• Six-digit HSN code change requirement should not be diluted to four-digit HSN code change during negotiations

The DoP has specifically requested industry feedback regarding:

• Feasibility of compliance by the domestic industry
• Any sensitivities, operational concerns, or trade implications
• Justification for the proposed rules
• Prevailing industry practices and relevant international benchmarks

In this regard, members are requested to kindly review the proposed recommendations and share their comments/suggestions, particularly from the perspective of the IVD and diagnostics sector.

Inputs may specifically cover:

• Impact on domestic manufacturing competitiveness
• Supply chain dependencies/import sensitivities
• Practical challenges in meeting value addition thresholds
• Suitability of six-digit HSN code change requirements
• Alignment with global RoO practices in FTAs

Members are requested to share their inputs with the ADMI Secretariat at the earliest to enable consolidation and submission to the Department within the stipulated timeline.

We look forward to your valuable feedback and active participation.

Regards,

Rajat Kapoor Assistant Director – Secretariat, Association of Diagnostics Manufacturers of India, TR-217, 2nd Floor, AltF 101 Okhla, NH-19, CRRI, Ishwar Nagar, New Delhi-110044 secre...@admi-india.org | +91 95993 58095

---------- Forwarded message ---------
From: Ananya Mamgaain <yp2-inte...@pharma-dept-consultant.gov.in>
Date: Fri, May 8, 2026 at 5:21 PM
Subject: Inputs on Product Specific Rules (PSRs) ROO - reg.
To: praveenmittal <praveen...@epcmd.in>, edepcmd <ed.e...@yamunaexpresswayauthority.com>, sankalpbhatia <sankalp...@epcmd.in>, dg <d...@pharmexcil.com>, regulatory <regul...@pharmexcil.com>, directorrodelhi <director...@pharmexcil.com>, admin <ad...@idmaindia.com>, akmadanidma <akmada...@gmail.com>, daara <da...@idmaindia.com>, sapna <sa...@idmaindia.com>, amittalwar <amit....@ipa-india.org>, sudarshanjain <sudarsh...@ipa-india.org>, archanajatkar <archana...@ipa-india.org>, info <in...@bdmai.org>, ed <e...@bdmai.org>, Rakesh Bhatia <rakesh...@aimedindia.com>, forumcoordinator Aimed <forumcoo...@aimedindia.com>, shubhankarb <shubha...@epcmd.in>, directorromumbai <director...@pharmexcil.com>, rollins <rol...@pharmexcil.com>, secretariat <secre...@admi-india.org>
Cc: Vishal V Nair <head-intern...@pharma-dept.gov.in>, Hitendra Sahu <divhead-inte...@pharma-dept.gov.in>, Giriraj Prasad Meena <us-interna...@pharma-dept.gov.in>, Ekta Barkhodia <so-interna...@pharma-dept.gov.in>, Anidhya <yp1-inte...@pharma-dept-contractor.gov.in>

Sir/Madam,

                   With reference to Product Specific Rules (PSRs) under Rules of Origin (RoO), it is apprised that the Department’s recommendations in the recently concluded Free Trade Agreements are as follows:-

 

Category	Chapter	Total TLs	Department of Pharmaceuticals’ PSR recommendation
Bulk drugs	17	6	Six-digit HSN code change OR 35-40% value addition. ·         Value addition not to exceed 40% during negotiations.
	28	1
	29	254
	38	2
	96	1
Formulations	30	197	Four-digit HSN code/Six-digit HSN code change OR 35-40% value addition. ·         Value addition not to exceed 40% during negotiations.
	35	4
	98	1
Medical devices	30	21	Six-digit HSN code change OR 35-40% value addition. Value addition not to exceed 45% during negotiations. ·         Six-digit HSN code change requirement not to be diluted to four-digit HSN code change during negotiations
	37	1
	38	7
	39	2
	40	5
	62	5
	84	1
	90	101
	94	4
	96	5
Total		618

 

2.         In this regard, pharmaceutical and medical devices industry associations/stakeholders are requested to furnish their inputs/comments on the aforesaid PSR recommendations, particularly with respect to the feasibility of compliance by the domestic industry, any sensitivities or concerns involved, and justification for the proposed rules, including prevailing industry practices and relevant international benchmarks.

3.           It is requested that the above-mentioned inputs may be provided to the Department at the earliest.

Regards,

Ananya Mamgaain

Young Professional (International Cooperation Division)

Department of Pharmaceuticals

Ministry of Chemicals and Fertilizers

Government of India

Janpath Bhawan, New Delhi - 110 001