Published on: 9th July 2026
Authored by: Sana Ravi Sapkal
Pravin Gandhi College of Law, Mumbai
Abstract
This article provides a comprehensive legal critique of the Draft Drugs, Medical Devices and Cosmetics Act, 2025, evaluating its capacity to overhaul India’s pharmaceutical governance.[4] India’s pharmaceutical sector accounts for a major portion of global drug volume and meeting up to seventy percent of the World Health Organization’s global vaccine supplies, yet it remains anchored to the archaic Drugs and Cosmetics Act, 1940.[1] Following a sequence of international and domestic pharmaceutical tragedies, including the loss of nineteen children in Madhya Pradesh in October 2025 due to diethylene glycol contamination, the Central Government introduced a revamped legislative blueprint.[4] This article analyzes the major provisions of the Draft Act, including the statutory empowerment of the Central Drugs Standard Control Organisation (CDSCO), the creation of a specialized Medical Devices Technical Advisory Board (MDTAB), strict mandates for clinical trial compensation, and the oversight of e-pharmacies.[4] Finally, the study examines unresolved systemic vulnerabilities, such as enforcement fragmentation across state lines and weak penal provisions, to determine whether this text represents a genuine paradigm shift or a missed opportunity in administrative reform.
I. Introduction
India’s pharmaceutical industry, widely recognized as the pharmacy of the world, stands as one of the largest and most rapidly expanding economic sectors globally.[1] It ranks third worldwide in pharmaceutical production by volume and exports critical therapeutics to over two hundred sovereign nations.[1] Furthermore, between sixty-five to seventy percent of the World Health Organization’s (WHO) global vaccine requirements are supplied by Indian manufacturing units.[1] Despite this massive industrial scale, the regulatory architecture governing these operations remains anchored to an outdated statutory framework enacted during the colonial era.[1]
The Drugs and Cosmetics Act, 1940 has long served as the primary legislation regulating the manufacture, import, and distribution of therapeutic substances within India.[1] This statute has faced intense criticism for its inability to manage the complexities of modern bio-pharmaceutical engineering, commercial distribution channels, and advanced health technologies.[1] Regrettably, it required a succession of public health crises to pressure the state into pursuing wholesale legislative reform.[1] In October 2025, nineteen children died in Madhya Pradesh after consuming a toxic batch of domestically manufactured cough syrup.[4] Subsequent laboratory evaluations revealed lethal concentrations of diethylene glycol, a hazardous industrial solvent, well above permissible regulatory thresholds.[4] This tragedy marked the fifth major mass-contamination event tied to Indian-manufactured syrups within a five-year window, following lethal incidents in Jammu in 2020, the Gambia and Uzbekistan in 2022, and Cameroon in 2023.[4] These events drew sharp criticism from the WHO regarding structural blind spots in India’s drug oversight apparatus.[4]
In direct response to these regulatory failures, the Drugs Controller General of India (DCGI) presented the Draft Drugs, Medical Devices and Cosmetics Act, 2025 during a high-level ministerial conference chaired by the Union Minister of Health and Family Welfare, J.P. Nadda.[4] The proposed bill aims to completely replace the 1940 Act and align India’s domestic enforcement mechanisms with international standards.[4] Concurrently, the enactment of the Medical Devices (Amendment) Rules, 2026 on March 10, 2026, demonstrates that incremental administrative adjustments are already moving forward while the broader legislative draft awaits formal parliamentary enactment.[3] This article provides a rigorous critique of the Draft Act of 2025, maps its core pillars, and evaluates whether it delivers real structural reform or simply represents another delayed update in India’s pharmaceutical history.
II. Historical Background: The Drugs and Cosmetics Act, 1940
Prior to 1940, India lacked a centralized legislative framework to regulate the quality, safety, and uniformity of manufactured pharmaceuticals. This legal vacuum allowed the sale of adulterated and substandard therapeutic products to expand unchecked, forcing the colonial government to intervene. Following the recommendations of the Chopra Committee in 1930, the legislative assembly passed the Drugs Act, 1940, which was later expanded to include cosmetics via an amendment in 1964.[1] Although the framework was amended over the years to integrate traditional systems of medicine, including Ayurvedic, Siddha, and Unani drugs, and to introduce enhanced criminal penalties for spurious products in 1982 and 2008, the underlying architecture remained structurally inadequate.[1]
A primary flaw in the 1940 Act stems from India’s constitutional framework, which classifies public health as a state subject under the Seventh Schedule. This classification splits regulatory enforcement authority between the central Central Drugs Standard Control Organisation (CDSCO) and independent state drug regulatory boards. This institutional arrangement has caused severe jurisdictional fragmentation across the country. For example, a manufacturer denied a license by one state board can easily relocate operations to a different state with more permissive oversight. Furthermore, if a state authority cancels a manufacturer’s license due to contamination, the company can often continue distributing products across the country under a separate license obtained elsewhere, as cross-border investigations face significant legal hurdles. A drug inspector registered in Maharashtra possesses no statutory authority to inspect a manufacturing plant in Himachal Pradesh without the express consent and physical accompaniment of a local inspector, which often stalls urgent enforcement actions.
This jurisdictional fragmentation is further worsened by severe understaffing and resource deficits across both central and state regulatory bodies. A 2013 Parliamentary Committee Report calculated that India required a minimum operational strength of 3,200 drug inspectors to handle domestic production volumes; however, the actual national count stood at just 1,427 in September 2015. By December 2023, the CDSCO operated with a working strength of only 201 inspectors against a sanctioned capacity of 504. Drug testing laboratories face similar operational deficits. Although the central government maintains eight labs alongside twenty-nine state facilities, a large portion of these testing assets remain underutilized. For example, between April 2015 and January 2019, Uttarakhand’s state laboratory tested only 226 pharmaceutical samples despite possessing a sanctioned annual capacity of 750 samples.
The real-world consequences of these regulatory loopholes have been severe. In 2022, contaminated cough syrups manufactured by Maiden Pharmaceuticals were linked to the deaths of over seventy children in the Gambia.[5] More than two years after the international scandal, no formal criminal prosecutions have been successfully finalized against the company’s executive leadership, while state investigations remain open.[5] Similarly, when the managing director of Maiden Pharmaceuticals was convicted in 2023 for exporting substandard medicines to Vietnam, the judicial verdict arrived a full decade after the initial offense took place. These gaps extended to medical devices as well. In 2003, Johnson & Johnson and its subsidiary DePuy imported 15,829 Articular Surface Replacement (ASR) hip implants into India.[6] These devices were subsequently utilized by orthopedic surgeons in over 4,700 operations across the country.[6] Many patients suffered severe localized tissue degradation, chronic pain, and systemic metal toxicity.[6] Because India lacked a dedicated statutory framework for medical devices, these advanced implants were regulated under the same generic rules as conventional pharmaceutical pills under the 1940 Act.[6] This legislative framework lacked provisions for post-market clinical surveillance, trace tracking of medical implants, or mandatory corporate liability for device defects.[6] Consequently, while nations like Australia and the United States issued swift product recalls and financial restitution programs, Indian regulators issued a recall notice only after thousands of defective units had already been surgically implanted.[6]
III. An Overview of the Draft Drugs, Medical Devices and Cosmetics Act, 2025
On October 15, 2025, the DCGI presented the official text of the Draft Drugs, Medical Devices and Cosmetics Act, 2025, to the Ministry of Health and Family Welfare.[4] This legislative proposal seeks to completely repeal the eighty-five-year-old framework of the 1940 Act.[4] The push for this bill accelerated after the CDSCO released its annual performance analysis, which revealed that 3.2 percent of approximately 5,500 drug samples collected across the country were substandard or counterfeit, underscoring the urgent need for a stronger legal framework.[4]
The core structural changes introduced by the proposed bill are organized into five primary regulatory areas:
A. Statutory Empowerment of the CDSCO
The Draft Act grants independent statutory powers to the CDSCO for the first time since its inception.[4] Under the 1940 Act, the central body lacked direct enforcement mechanisms, leaving it dependent on state boards to execute product recalls and issue penalties.[4] The 2025 text cures this defect by empowering central regulators to order immediate national market recalls, freeze non-compliant manufacturing production lines, and initiate independent criminal prosecutions against rogue manufacturers without requiring state board approval.[4]
B. Distinct Medical Device Regulatory Track
Moving past the practice of treating advanced equipment as a sub-category of generic medicines, the Draft Act creates an independent regulatory framework for medical devices.[4] It establishes a specialized Medical Devices Technical Advisory Board (MDTAB), which operates independently from the traditional Drugs Technical Advisory Board (DTAB).[4] The MDTAB will include experts in biomechanical engineering, biomaterials, nuclear physics, defense research, and clinical investigation.[4] Furthermore, the draft mandates the construction of dedicated medical device testing laboratories at both central and state levels to prevent future public health crises like the DePuy implant scandal.[4]
C. Clinical Trial Accountability and Oversight
The Draft Act introduces stricter regulations for human clinical trials, requiring prior written authorization from the Central Licensing Authority before commencing any trial or clinical investigation for drugs or medical devices.[4] The text makes medical management and financial compensation mandatory for any injuries or deaths during clinical trials.[4] Violations of these safety provisions carry severe criminal penalties, including mandatory imprisonment and fines up to double the total compensation figure if a manufacturer fails to pay the victims.[4] Purely academic research and basic biomedical trials are exempt from these commercial compliance requirements.[4]
D. Digitization and Inter-State Coordination Channels
To fix the historical issues caused by jurisdictional fragmentation, the Draft Act introduces a unified digital licensing infrastructure designed to standardize data sharing across state boundaries.[4] It also establishes an advisory body called the Drugs, Medical Devices and Cosmetics Consultative Committee (DMDCCC), chaired by the DCGI.[4] This committee is tasked with standardizing enforcement actions across different states to prevent manufacturers from exploiting local regulatory gaps.[4]
E. Comprehensive E-Pharmacy Regulation
The Draft Act plugs a major regulatory gap in the 1940 Act by making it illegal for any entity to sell, stock, exhibit, or distribute medications through online platforms without holding a valid e-pharmacy license.[4] The central government is granted full statutory authority to design specific rules governing digital pharmacy networks.[4]
IV. Conclusion
India’s pharmaceutical industry continues to face serious regulatory hurdles despite its rapid growth. The Draft Drugs, Medical Devices and Cosmetics Act, 2025, represents the most comprehensive attempt to modernize the country’s pharmaceutical governance by introducing statutory powers for the CDSCO, a separate regulatory track for medical devices, and mandatory compensation for clinical trials.[4] Additionally, the enactment of the Medical Devices (Amendment) Rules, 2026, confirms that targeted regulatory adjustments are already moving forward while Parliament reviews the broader bill.[3]
However, several critical gaps remain unaddressed in the current draft. The bill lacks a clear post-market surveillance framework for high-risk medical devices, leaving a significant vulnerability in consumer safety. Furthermore, domestic manufacturing groups argue that the text favors multinational corporations and conflicts with the self-reliance goals of the National Medical Device Policy 2023, with ten major industry associations calling for two separate laws to govern drugs and medical devices independently. Centralizing authority within the understaffed CDSCO risks repeating old enforcement delays under a new name, while several penalty provisions have been weakened by substituting monetary fines for mandatory imprisonment.
While the 2025 draft marks a significant shift away from colonial-era regulations, these structural and resource gaps must be solved if the law is to have a meaningful impact. Ultimately, the success of the bill depends not just on whether India can manufacture medicines that meet international standards, but on its political commitment to ensuring that domestic consumers receive the same quality and safety protections as international buyers.
References
[1] Drugs and Cosmetics Act, No. 23 of 1940, India Code (1940).
[2] Medical Devices Rules, 2017, G.S.R. 78(E) (2017).
[3] Medical Devices (Amendment) Rules, 2026, Ministry of Health and Family Welfare (enacted Mar. 10, 2026).
[4] Draft Drugs, Medical Devices and Cosmetics Act, 2025, Central Drugs Standard Control Organisation (introduced Oct. 15, 2025).
[5] Dinesh S. Thakur & Prashant Reddy T., The Truth Pill: The Myth of Drug Regulation in India (Simon and Schuster, 2022).
[6] Vidya Menon, Regulatory Gaps in India’s Medical Device Framework: The Case of Johnson and Johnson’s Faulty Hip Implants, 15(12) WORLD J. ORTHOPAEDICS 1124 (2024).
