The Ministry of Health and Family Welfare (Govt. of India) on January 18, 2022, has issued the Drugs (Amendment) Rules, 2022 to further amend the Drugs Rules, 1945.
The amendment makes QR codes mandatory on every active pharmaceutical ingredient. The Amendment Rules will come into force from January 01, 2023.
In Rule 96 Relating To The Manner Of Labelling, The Following Sub-rule Shall Be Inserted:
According to the gazette notification, the new drug amendments rule states that every active pharmaceutical ingredient (API) imported or manufactured in India shall bear a QR (quick response) code on the label and at every packaging level. The QR code must encase essential data that can be read through computer software for efficient tracking and tracing.
Special storage conditions required (if any). This amendment will come into force on the 1st of Jan 2023. You will need to implement a solution before that.
The Stored Data Must Contain the Following Information
- Unique product identification code
- Name of the API
- Brand name (if any)
- Name and address of the manufacturer
- Batch no.
- Batch size
- Date of manufacturing
- Date of expiry or retesting
- Serial shipping container code (SSCC)
- Manufacturing licence no. or import licence no.
Reference:
https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/
A significant uptick in M&A activity in the biosimilars sector is being driven by FDA regulatory reforms, a maturing patent litigation framework and a looming patent cliff — $200 billion of branded products are facing patent expiration by 2030.
The Drewry World Container Index edged lower this week as falling Asia-Europe rates outweighed firmer pricing on the Transpacific, with carriers preparing another round of blank sailings ahead of China’s Golden Week holiday.
On 14 July 2026, the European Parliamentary Research Service (EPRS) published a comprehensive briefing on PFAS (per- and polyfluoroalkyl substances), also known as ‘forever chemicals’. The document is intended to serve as a technical basis for MEPs in their upcoming political decisions on PFAS regulation and summarises the current state of scientific knowledge, regulation and procedures.
Following a series of typhoon disruptions in East China during the month of August, major ports including Shanghai and Ningbo continue to experience congestion and operational recovery challenges. Industry reports indicate that vessel schedules, yard operations, and equipment circulation remain affected as terminals work through accumulated backlogs from successive storm events.
Under REACH Annex XVII Entry 78, the EU has banned the placing on the market of synthetic polymer microparticles (SPMs) unless a specific derogation applies. Derogations exist for essential uses such as:
As a result of the amendment of the CLP Regulation (Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures), new hazard classes have entered into force.
In a converging policy shift on both sides of the Atlantic, European regulators this week published a roadmap toward fully replacing animal testing for chemical safety assessments, while the US Environmental Protection Agency issued a rare update to its list of alternative test methods.
The global pharmaceutical fine chemicals sector is undergoing a profound transformation, with India emerging as a central growth engine amid sweeping changes in supply chain strategies and regulatory priorities. As drug makers and contract manufacturers adapt to stricter oversight and evolving sourcing preferences, the industry’s focus is shifting rapidly from cost efficiency to compliance, localisation and technical sophistication.
Stakeholders are being encouraged to weigh in on the European Chemicals Agency (ECHA) 60-day public consultation period related to a planned ban on per-and-polyfluoroalkyl (PFAS) substances, also known as forever chemicals.