BioSpectrum India
October 2025

India's Pharma Reforms Target Global Credibility
The Indian government has introduced several measures to simplify drug approvals and support innovation. Key reforms include updating the New Drug and Clinical Trial Rules (2019) and using digital platforms to handle regulatory submissions, with the goal of improving transparency, reducing approval timelines, strengthening pharmacovigilance, and maintaining quality standards. What do these reforms entail, how is the industry responding, and what steps lie ahead to make India's pharmaceutical sector globally competitive? Let's find out.

ARTICLES

Navigating Cold Chain Challenges with AI Solutions

Artificial intelligence (AI) is playing a key role in driving the growth of the ever-demanding cold chain logistics sector, which caters to both the pharmaceutical and healthcare industries. The role of AI in enabling real-time temperature tracking and anomaly alerts, reducing spoilage and degradation of sensitive goods, optimising routing, scheduling, and load planning, leading to more efficient delivery and fuel savings, is noteworthy. Both the cold chain and AI players are optimistic about the future growth with a rising demand for life sciences products.

Navigating Cold Chain Challenges with AI Solutions

Revitalising Cosmetic Standards & Compliance

A huge craze among consumers for cosmeceuticals, by going into marketing and brand appeal, is setting a dangerous precedent. Above all, fake cosmetic products have flooded the Indian market, which are easily available online and across street markets. Keeping this in mind and to stop unscrupulous ads, the Ministry of Health and Family Welfare has officially published the Cosmetics (Amendment) Rules, 2025, which introduce a series of changes to the existing Cosmetics Rules, 2020. Experts weigh in on how this Act can be a game-changer in the cosmeceutical sector, provided strict norms are followed.

Revitalising Cosmetic Standards & Compliance

How Waste Management Strategies Can Transform Indian Pharma Manufacturing

Sustainability will be a key success factor as India's pharmaceutical industry enters its next stage of expansion. Pharma manufacturing has a revolutionary chance to improve operational efficiency and safeguard the environment and public health through waste management. Use cases from industry implementation demonstrate that progressive waste management is feasible because enterprises are developing innovative solutions, technologies are available, and supportive policies are starting to emerge.

How Waste Management Strategies Can Transform Indian Pharma Manufacturing

Can DPDPA’s Research Exemption Power Private Sector Breakthroughs?

India’s Digital Personal Data Protection Act, 2023 (DPDPA), imposes uniform data protection obligations across sectors, significantly affecting healthcare, pharma, and biotech firms due to their use of sensitive personal data. Section 17(2)(b) provides limited exemptions for “research, archiving, or statistical purposes,” which some stakeholders interpret as broad immunity. This article challenges that view, arguing that Indian policy generally restricts exemptions for private, profit-driven research unless a clear public interest is demonstrated. Drawing on parallels with the GDPR, it concludes that the exemption will likely be narrowly construed, and the forthcoming DPDPA Rules are unlikely to support a wide carve-out.

Can DPDPA’s Research Exemption Power Private Sector Breakthroughs?

How AI Is Accelerating Drug Repurposing & Therapeutic Innovation in India

With India facing increasing disease burdens and deficiencies in healthcare infrastructure, AI is becoming a driving force for quicker, more intelligent therapeutic advancements. Indian startups and institutions are making significant contributions through drug repurposing, enhancing diagnostics, genomics, and clinical research.

How AI Is Accelerating Drug Repurposing & Therapeutic Innovation in India

India's Pharma Reforms Target Global Credibility

The Indian government has introduced several measures to simplify drug approvals and support innovation. Key reforms include updating the New Drug and Clinical Trial Rules (2019) and using digital platforms to handle regulatory submissions, with the goal of improving transparency, reducing approval timelines, strengthening pharmacovigilance, and maintaining quality standards. What do these reforms entail, how is the industry responding, and what steps lie ahead to make India’s pharmaceutical sector globally competitive? Let’s find out.

India's Pharma Reforms Target Global Credibility

INTERVIEWS

Interview Avatar
"India is Shaping the Future of Global Life Sciences"

Dr Rajeev Gautam

Senior Corporate Officer – HORIBA, Ltd., Japan
President – HORIBA India

Interview Avatar
“Despite high disease burden, there are no national screening guidelines for multiple myeloma in India”

Heejin Roh

Vice President – Commercial Operations,
Asia Pacific, Sebia, South Korea

WATCH NOW