Pharma Industry

Centre proposes mandatory qualified personnel for drug batch release

The proposed amendments seek to strengthen accountability in drug manufacturing by requiring qualified personnel for batch release and maintaining prescribed records

Pharma industry seeks clarity on CDSCO solvent order's export ambit

Pharma executives seek clarity on export applicability of CDSCO's batch-wise solvent clearance rules, warning that approval delays could disrupt supplies, particularly in rural markets

Centre proposes expanding import gateways for drugs, medical devices

The Union Health Ministry has proposed expanding the network of authorised import gateways for drugs, medical devices and cosmetics by adding several inland container depots, a special economic zone and an international airport to facilitate faster clearance and improve supply chain efficiency. The proposed amendment to Rule 43A of the Drugs Rules, 1945, seeks to include additional entry points in Haryana, Uttar Pradesh, Gujarat, Telangana and Karnataka, according to a gazette notification issued by the ministry. The proposed locations include Inland Container Depots (ICDs) at Sonipat, Piyala and Harsaru in Haryana; Dadri in Uttar Pradesh; Gandhidham/Mundra in Gujarat; Sanath Nagar and Thimmapur in Hyderabad; and Whitefield in Bengaluru. The ministry has also proposed including the Bommasandra Special Economic Zone (SEZ) in Karnataka and Noida International Airport in Uttar Pradesh for the import of drugs by air. Rule 43A specifies the authorised ports, airports, railway stations,

CDSCO mandates digital batchwise clearance for high-risk pharma solvents

Drug regulator CDSCO has mandated digital clearance for every batch of high-risk pharmaceutical solvents, prompting industry concerns over delays and potential supply disruptions

ERP transformation key to ensuring pharma manufacturing continuity: Experts

Modernising pharma through enterprise resource planning (ERP) transformation replaces vulnerable legacy systems with a single source of truth, ensuring uninterrupted manufacturing continuity, according to experts. "This digital evolution gives life sciences companies the agility and data integrity needed to seamlessly meet strict regulatory requirements," Mandar Ghatnekar, Chief Technology Officer, Biocon, said while addressing the 15th edition of the Pharma IT Summit Mumbai 2026 organised by Exito Media Concepts earlier in the week. Speakers from top pharmaceutical companies, who attended the summit, also advocated for the need for human review of GenAI outputs, particularly in a good practice (GxP) environment. "In a highly regulated industry like pharmaceuticals, successful AI adoption requires a strong foundation of people, process, technology and governance, balancing innovation with regulatory compliance and operational excellence. "The future of AI will be defined not by how

Cipla Q2 net profit falls 35% to ₹877.5 cr, revenue declines marginally

Pharmaceutical major Cipla on Tuesday reported a 35 per cent decline in its consolidated net profit for the second quarter ended September at 877.54 crore, as revenue fell marginally while expenses grew during the period. The company had posted a net profit of Rs 1,351.17 crore during the corresponding period a year ago, a regulatory filing showed. During the July-September quarter under review, total revenue from operations declined to Rs 7,403.93 crore, from Rs 7,589.44 crore a year ago. Meanwhile, total expenses rose to Rs 6,377.75 crore, from Rs 6,004.86 crore in the second quarter of the previous financial year.

Centre forms 3-member panel to review pharma marketing code, enforcement

The three-member committee will assess the effectiveness of the UCPMP, examine enforcement mechanisms and recommend measures to curb unethical pharmaceutical marketing practices

GLP-1 boom in India, China, Brazil can create $22 bn market: JP Morgan

The addressable ​market could grow at an annual rate of 15% through 2035, JP Morgan ‌analysts led by Yang Huang said in a note on Friday, given the countries' large diabetes and obesity burdens

GST Council may give export status to clinical trials for overseas sponsors

Proposals include ITC relief on free samples and expired drugs, while a 90% refund of accumulated credit could ease working-capital pressure for drugmakers

MSD appoints Vidhya Sundaram as Associate VP of Global Technology Centres

Pharmaceutical company MSD on Monday said it has appointed Vidhya Sundaram as Associate Vice President, Global Technology Centers, and Hyderabad Tech Center Lead. Vidhya, based in Hyderabad, will oversee MSD's global Technology Center strategy, working closely with global technology leaders to deepen collaboration across locations and support business outcomes, a company statement said. She will also lead the Hyderabad Tech Center, helping advance the digital capabilities that support MSD's work to deliver innovative solutions for human and animal health around the world. MSD, which operates as Merck & Co., Inc in the US and Canada markets, recently inaugurated the Tech Centre's expanded workplace in Hyderabad. Vidhya brings more than 20 years of experience building and scaling global capability organisations and driving business outcomes through digital and technology across the life sciences industry, the company said. Prior to joining MSD, Vidhya held leadership roles at Eli ...

Antibiotic sales decline, but concerns over inappropriate use remain

Pharmarack data show anti-bacterial unit sales falling since 2023; experts say lower volumes alone do not indicate more appropriate antibiotic use

Indian pharma market grows 10.7% in August despite 3-month volume low

Pharma sales value rose to Rs 23,272 crore in August, driven by new introductions and double-digit growth in key acute and chronic therapies, even as volume growth slowed

Natco Pharma to invest $14 mn in US-based biotechnology firm eGenesis Inc

Natco Pharma on Tuesday said it is investing USD 14 million (over Rs 130 crore) in eGenesis Inc, a US-based biotechnology firm, through its two subsidiaries. As part of the transaction, Natco Pharma (Canada) Inc will invest USD 9.5 million and Natco Pharma South Africa Proprietary Ltd USD 4.5 million in eGenesis through convertible promissory notes, the Hyderabad-based company said in a regulatory filing. eGenesis is pioneering a genome engineering-based approach in the development of safe and effective transplantable organs to end the global organ shortage and transform the treatment of organ failure, it added. In 2024, Natco Pharma had invested USD 8 million in eGenesis, Inc through preferred stock. The total investment made by it in eGenesis, Inc now stands at USD 22 million, the company said. The eGenesis Genome Engineering and Production (EGEN) platform is the only technology of its kind to comprehensively address cross-species molecular incompatibilities and viral risk via ..

Indian pharma firms have little reason to fear Trump's tariff threat

Trump's pledge to apply 100% levy on firms making off-patent medications by 2028 (rising to 200% a year later) unless they move production to US faces formidable commercial and political obstacles

India's pharma ambitions are running into a regulatory capacity constraint

Govt's decision under the ₹10,000 cr Biopharma SHAKTI programme to create a dedicated scientific review cadre within CDSCO is an important reform

Pharma sector must move from cost competitiveness to innovation: Experts

India's pharmaceutical industry needs to move beyond its traditional strength in cost-effective generic medicines and focus on innovation, advanced manufacturing, quality and global regulatory standards to realise its growth potential, industry experts said. With India targeting a pharmaceutical market of USD 130 billion by 2030, experts at a recent industry event in Hyderabad said the next phase of growth would require greater investments in research and development, digital technologies and contract research and development manufacturing. The discussions were held ahead of the 19th edition of CPHI & PMEC India 2026, scheduled to be held in November across venues in Delhi-NCR. The official launch and precursor event of CPHI & PMEC India 2026, held under the banner of the Pharma Leadership Exchange, brought together pharma leaders, CXOs, industry stalwarts, and key voices from across India's pharmaceutical and life sciences ecosystem. Sarvesh Singh, CEO, Lifesciences and ...

Indegene eyes clinical research acquisition to widen pharma services play

The company is evaluating specialised CROs, data-management and patient-recruitment businesses as it looks to expand across the pharmaceutical value chain

Thermo Fisher eyes 15-20% India customer growth on biopharma research boost

The US-based company said it is eyeing continued double-digit growth in India driven by rising demand from biopharma, semiconductor, and clean energy sectors

Regulatory hurdles eclipse tariff worries for pharma CXOs: Deloitte survey

Industry seeks AI-based submission tools and unified digital portals to accelerate approvals and compliance tracking

Fermenta Biotech expands plant-based Vitamin D3 capacity at Dahej plant

Dahej facility to begin commercial production in FY28; company targets nutraceuticals, functional foods and import substitution