New Labelling Rules: A Major Shift for Patient Safety and Pharma Industry

In a significant regulatory update, Indian authorities have introduced new labelling rules for pharmaceutical products to help patients select pills wisely and to improve medicine safety and transparency.

These new guidelines will transform the way medicines are packaged, labelled, and understood — not just by healthcare professionals but by common people, manufacturers, wholesalers, and the entire pharma ecosystem.

Key Features of the New Labelling Rules

Bold and Bigger Salt Name

The active pharmaceutical ingredient (API) must now be displayed prominently in bold, large fonts for better visibility.

Colour Coding System

• Prescription Drugs: Red strip
• OTC Medicines: Green band
• High-Risk Medicines: Yellow caution strip

Multilingual Labels

Essential instructions must now appear in English and regional languages.

QR Codes for Digital Details

Patients can now scan QR codes on medicine packs to get full product details, usage instructions, and safety warnings online.

Larger, Clearer Font Sizes

Dosage, expiry date, and storage instructions must be printed in readable, patient-friendly fonts.

Impact on the Pharma Supply Chain

For Manufacturers:

• Immediate packaging updates required
• Higher compliance costs but long-term patient trust

For Wholesalers:

• Easier inventory management with colour-coded packs
• Safer medicine distribution

For Patients:

• Safer self-medication
• Better medicine awareness and fewer errors
   

Latest Indian Pharma News (July 2025)

The Indian pharmaceutical sector is buzzing with big developments in manufacturing, exports, product launches, and strategic collaborations. Here's a quick round-up:

1. Nymi and Caliber Technologies Introduce Passwordless Pharma Authentication

Nymi, a leader in continuous authentication technology, has partnered with Caliber Technologies to bring passwordless authentication systems to pharma manufacturing, improving data security and process efficiency.

2. Pharmexcil Reports Strong Pharma Export Growth

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) announced exports worth $2,475.70 million in May 2025, bringing the year-to-date total to $4,961.71 million. This showcases India’s continued strength as a global pharma hub.

3. AstraZeneca Pharma India Gets CDSCO Approval for Endometrial Cancer Drug

AstraZeneca has secured CDSCO approval for its treatment of endometrial cancer, expanding its oncology portfolio in India.

4. Glenmark Pharmaceuticals Launches Tevimbra (tislelizumab) in India

Glenmark has launched Tevimbra (tislelizumab), a key immunotherapy drug, after receiving CDSCO approval, strengthening India’s cancer care options.

5. Lupin Receives USFDA Approval for Loteprednol Etabonate Ophthalmic Gel

Lupin’s eye care division gains a boost with USFDA approval for its Loteprednol Etabonate Ophthalmic Gel, opening new international market opportunities.

6. Torrent Pharma to Acquire JB Chemicals & Pharmaceuticals

Torrent Pharmaceuticals is set to acquire a controlling stake in JB Chemicals for ₹19,480 crore, signaling further consolidation in the Indian pharma industry.

7. Alembic Pharma Gets USFDA Nod for Doxorubicin Hydrochloride Liposome

Alembic Pharmaceuticals has secured USFDA approval for its Doxorubicin Hydrochloride Liposome injection, boosting its oncology portfolio.

8. Novo Nordisk Launches Wegovy in India

Novo Nordisk has introduced Wegovy, a weight loss drug, in the Indian market, priced at ₹17,345 per month, tapping into the growing obesity treatment segment.

9. Biocon Launches ₹4,500 Crore QIP

Biocon is raising ₹4,500 crore via Qualified Institutional Placement (QIP) to strengthen its financial position and support expansion in biosimilars and research.

What This Means for Pharma Businesses

• Manufacturers: Must quickly adopt the new labelling rules to stay compliant and competitive.
• Wholesalers & Distributors: Need to understand and manage updated packaging for smooth operations.
• Pharma Investors: Recent approvals and acquisitions indicate strong growth potential in oncology, eye care, and biosimilars.
• Patients: Can now expect clearer labels, better safety information, and wider access to innovative medicines.

Steris Healthcare Pvt Ltd: Committed to Smart Labelling and Patient Safety - At Steris Healthcare Pvt Ltd, we proudly align with the new labelling standards. We have always focused on providing clear, patient-friendly medicine packaging that promotes safe and informed use.

Why Steris Stands Out:

• Bold, clear display of active ingredients

• Colour-coded packs for instant identification

• Multi-language instructions to support diverse patients across India

• Quick-access QR codes for full medicine details

• Compliance with CDSCO guidelines and industry best practices

Since 2018, Steris Healthcare Pvt Ltd has been delivering doctor-trusted, result-driven medicines across multiple therapeutic categories. We are consistently promoted by healthcare professionals and chosen by wholesalers for our quality, reliability, and regulatory readiness.

If you’re a manufacturer, wholesaler, or distributor, partnering with Steris means choosing:

• Future-ready packaging
• Rapid compliance with evolving pharma laws
• High-demand, patient-centric products
• The new labelling rules and recent pharma developments are reshaping the Indian pharmaceutical landscape.

Conclusions

For patients:
  Safer, clearer, and smarter medicine choices.

For pharma businesses:
  A crucial time to upgrade, comply, and innovate.

For pharma investors:
 Robust opportunities across oncology, ophthalmology, weight management, and biosimilars.

Steris Healthcare Pvt Ltd – Redefining Patient Safety with Smarter Labelling and Trusted Medicines.