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Introduction
In the past couple of months, the healthcare and pharmaceutical sectors have undergone significant regulatory and policy shifts, highlighting a sustained focus on transparency, quality assurance, and industry facilitation. A key development during this period has been the introduction of the Pharmacy Council of India (Manner of Holding Inquiry and Imposition of Penalty) Regulations, 2025, bringing long-needed procedural clarity to disciplinary proceedings under the Pharmacy Act, 1948. This move aims to harmonise the framework for conducting inquiries and levying penalties across state pharmacy councils and plug long-standing procedural gaps.
On the pharmaceutical front, the Central Drugs Standard Control Organisation has mandated exclusive use of the Online National Drugs Licensing System portal for procurement of World Health Organisation Good Manufacturing Practices Certificate and Certificate of Pharmaceutical Products – an important step toward digitization and simplification of compliance processes. In parallel, medical device reforms, from eased sterilisation norms to updated skill development guidelines, reflect a push for operational efficiency and capacitybuilding.
In this edition of 'Checking the Pulse', we delve into the key updates pertaining to the months of June 2025 and July 2025.
Government Initiatives
Pharmacy Council of India notifies inquiry and penalty regulations on violations of provisions under Pharmacy Act, 1948
On June 10, 2025, the Pharmacy Council of India ("PCI") notified the Pharmacy Council of India (Manner of Holding Inquiry and Imposition of Penalty) Regulations, 2025 ("New Regulations") to provide clarity on the manner of holding inquiry and imposing penalty for any violations under the Pharmacy Act, 1948 ("Pharmacy Act").1
Pertinently, although Section 18(i) of the Pharmacy Act empowers PCI to formulate regulations governing the manner of holding inquiry and imposition of penalty for violation of the Pharmacy Act, there was no procedural clarity in this regard prior to the notification of the New Regulations. The New Regulations aim to fill in this void and bring consistency in the inquiry mechanism across all state pharmacy councils.
The step-wise procedure prescribed under the New Regulations is outlined below:
(a) Eligibility to File Complaint: Any person can file a complaint in Form-I (specifically set out in the New Regulations) through electronic means or speed post or in person, to the adjudicating officer regarding contravention of the provisions of the Pharmacy Act.
(b) Issuance of Show Cause Notice: The adjudicating officer, as authorised under Section 43A of the Pharmacy Act, shall issue a show cause notice to the person against whom the complaint has been filed. If the adjudicating officer is satisfied that an inquiry should be held in the matter, the adjudicating officer can even proceed to issue a notice of appearance to the person (against whom allegations have been made) to appear either themselves or through a representative. The onus has been entrusted on the person in receipt of the afore-mentioned notice to explain as to why an inquiry should not be initiated against him. This explanation ought to be furnished within the time specified in the notice, being not less than 7 (seven) days from the date of service of the notice. Further, the New Regulations require the notice to clearly specify the alleged violation committed.
(c) Modes of Service of Notice or Order: Notices or orders under the New Regulations may be served on a person by delivering them directly to the individual or their authorized representative, sending them electronically or by registered/ speed post to their current or last known residential or business address. If these methods are not viable, they can also be served by affixing them to a prominent part of the premises where the person resides, last resided, carried on business or worked for gain.
(d) Authority to Issue Ex-Parte Order: If the person against whom the complaint has been filed fails, neglects, or refuses to appear before the adjudicating officer, the adjudicating officer may proceed with the inquiry in his absence after recording the reason for doing so.
(e) Manner of Taking Evidence: The adjudicating officer shall give an opportunity to the accused person to produce documents and evidence in Form-III (specifically set out in the New Regulations) as he may consider relevant to the inquiry. The evidentiary process underpinning the scenario herein is not bound by the provisions of the Bharatiya Sakshya Adhiniyam, 2023. The adjudicating officer is also conferred with the authority to summon and secure the attendance of any person with knowledge of the matter, or to require the production of documents deemed relevant to the proceedings.
(f) Imposition of Penalty: If the adjudicating officer, after examining the evidence produced, is satisfied that the person accused has committed the contravention, he may, by an order in writing, impose such penalty under the Pharmacy Act, as he considers reasonable. The order shall specify the provision of Pharmacy Act in respect of which contravention has been committed and shall also specify the reasons for imposition of the penalty.
(g) Timeline for Completion of Proceedings: The adjudicating officer must complete the proceedings within 6 (six) months from the issuance of the notice pursuant to a complaint.
(h) Filing and Processing of Appeals: Any person aggrieved by an order of the adjudicating officer under the New Regulations may prefer an appeal to the appellate authority in Form-IV (specifically set out in the New Regulations). Such appeal shall be filed within a period of 45 (forty-five) days from the date of receipt of the order from the adjudicating officer. The appeal may be admitted even after the expiry of the afore-stated period, if the appellant satisfies the appellate authority that he had sufficient cause for not preferring the appeal within the prescribed period.
The appeal must be filed with a copy of the adjudicating officer's order, a clear statement of facts, grounds of appeal and details of the alleged contraventions. It is to be submitted in triplicate, either in person, through an authorized representative or by registered/ speed post or electronic means. The appellate authority will subsequently serve a copy of the appeal on the respondent, who must file a reply within 30 (thirty) days of receiving the copy. As per the New Regulations, the appellant authority is required to dispose of the appeal within 90 (ninety) days from the date of filing of the appeal.
Central Drugs Standard Control Organisation streamlines the application process for procurement of World Health Organisation Good Manufacturing Practices Certificate and Certificate of Pharmaceutical Products
On June 25, 2025, the Central Drugs Standard Control Organisation ("CDSCO") directed drug controllers across India to ensure that manufacturing units operating in their respective jurisdictions submit applications for procurement of: (a) World Health Organisation ("WHO") Good Manufacturing Practices Certificate ("WHO-GMP"); and (b) Certificate of Pharmaceutical Product ("COPP") exclusively through the Online National Drugs Licensing System portal ("ONDLS Portal").2
The WHO-GMP certificate serves as an indicator of a pharmaceutical manufacturer's compliance with the quality assurance standards recommended by the WHO. This certification is a mandatory prerequisite for obtaining a COPP, which is a product-specific certificate, required for the registration and marketing of pharmaceutical products in India.
Before applying for the grant of WHO-GMP certificate, the applicants are required to get the details of their license and product approved on the ONDLS Portal. The ONDLS Portal serves as a single window platform for online processing of various applications for issuance of manufacturing and sales licenses including blood banks, market standing certificate etc., and post approval changes.
This digitalization initiative replaces the earlier, more cumbersome process of manual submissions. Under the erstwhile framework, applicants were required to submit supporting documents such as manufacturing license copy, product lists, site master file, compliance related undertakings etc., in physical form to the Drug Controller General of India ("DCGI") for procurement of the afore-mentioned certificates. The manual submission process was not only time-consuming but also prone to inconsistencies and lacked a digital tracking mechanism.
By moving the entire application process for procurement of WHO-GMP and COPP to the ONDLS Portal, the CDSCO aims to streamline the licensing application and approval process and enhance the ease of doing business in India. By digitizing the licensing application and approval process, substantially reducing the paperwork, and eliminating redundancies, the centralized online system is expected to facilitate improvement in tracking of applications. Further, the air is sanguine for provision of a uniform platform for stakeholders across the country to strike a balance between ease of doing business in India and aligning the regulatory framework with global best practices.
Free Trade Agreement between India and the United Kingdom grants zero-duty access to generic drugs and medical devices
In a welcome move for industry stakeholders in the country, India and the United Kingdom ("UK") entered into a Free Trade Agreement ("FTA") on July 24, 2025, with the aim of eliminating regulatory and import barriers and promoting long-term collaboration.3 The FTA sets out several crucial changes with respect to the pharmaceutical and medical devices industries, which have been discussed in detail below:
(a) Complete Removal of Tariffs on Import of Indian Medical Devices: For Indian exporters, the FTA envisions a complete removal of the 2% (two percent) to 6% (six percent) tariff rates currently applicable on a wide range of products, including surgical instruments, diagnostic equipment, ECG machines, and X-ray systems. This is expected to lower input costs for Indian exporters and improve price competitiveness in the medical devices sector in the UK. India's export of medical devices to UK was valued at USD 37 Million (United States Dollars Thirty-Seven Million) in 2024, which is expected to see a significant rise once these changes come into effect.
(b) Reduction of Tariffs on Import of UK Medical Devices: Export of medical devices by the UK to India shall attract significantly reduced import duties henceforth. The current tariffs, which stand at approximately 15% (fifteen percent), are slated to be reduced to around 3% (three percent).4 This reduction will make UK-made advanced medical technology more accessible and affordable for the Indian healthcare sector. The FTA outlines a phased implementation where tariff reductions are staggered over several years, with specific timelines for different categories of medical equipment.
(c) Complete Exemption from Customs Duty on Pharmaceutical Exports: The FTA offers greater regulatory certainty and zero-duty guarantees for active pharmaceutical ingredients, bulk drugs, and finished formulations. This is likely to accelerate the entry of cost-effective generics and biosimilars into the UK market, India's largest pharmaceutical export destination in Europe. Although pharmaceuticals account for only 56 (fifty-six) tariff lines constituting to be 0.6% (zero point six percent) of the total, the sector holds substantial strategic and economic value in global trade. It is poignant to note that despite India currently exporting USD 23.31 Billion (United States Dollars Twenty-Three point Three One Billion) worth of pharmaceuticals worldwide, and the UK importing nearly USD 30 Billion (United States Dollars Thirty Billion) worth of pharmaceuticals, Indian exports to the UK remain below USD 1 Billion (United States Dollars One Billion). This highlights the significant untapped potential, and the zero tariff provisions under the FTA are expected to combat this issue and strengthen the competitiveness of Indian generics in the UK, thereby creating considerable opportunities for growth.
(d) Mutual Recognition of Regulatory Frameworks: On the regulatory front, there is a push to promote good regulatory practices and enhance bilateral cooperation. In furtherance of these objectives, the FTA requires both UK and India to ensure that their regulations are made accessible, and that interested stakeholders are provided a reasonable opportunity to comment on proposed major regulatory measures. Further, the FTA envisions measures like retrospective reviews, regulatory impact assessments and information exchanges as means to enhance bilateral trade and investment between the countries by fostering a transparent environment while recognizing each country's unique development and sovereign right to regulate.
Industry stakeholders have hailed this decision, emphasizing on the FTA's potential to significantly enhance India's market access in UK and expand collaborations through partnerships, joint research, and technology transfer. Additionally, with the UK reducing its dependence on Chinese imports in the post-Brexit and post COVID-19 landscape, Indian manufacturers are well placed to become a preferred, cost-effective supply source. The zero-duty pricing advantage for medical devices under the FTA strengthens India's competitive edge, opening new avenues for market expansion and long-term trade partnerships.
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Footnotes
1. The New Regulations can be accessed here: https://pci.gov.in/documents/1298/Gazette.pdf
2. The notice can be accessed here: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCircularFile/Circular%20for%20COPP%20through%20ONDLS%20portal.pdf
3. The FTA can be accessed here: https://www.commerce.gov.in/international-trade/trade-agreements/india-united-kingdom-comprehensive-economic-andtrade-agreement/
4. The relevant news article can be accessed here: https://www.ndtv.com/world-news/tariffs-on-uk-products-in-india-to-drop-from-15-to-3-under-newtrade-deal-8940121
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