Page 143 - CW E-Magazine (27-8-2024)

Pharmaceuticals

GOOD-DISTRIBUTION PRACTICES
DCGI introduces new traceability rules to address

fake medicines issue

India’s leading drug regulator, the seamlessly could prove vital in identify- practices into the Drugs and Cosmetic
Drugs Controller General of India ing the exact point in the supply chain Rules, 1945, as a formal Schedule. The
(DCGI), has established standard opera- where adulteration occurred or where discussion highlighted that due to the
ting procedures and guidelines aimed counterfeit drugs were introduced. non-mandatory nature of existing guide-
at enhancing product traceability across lines, there has been a lack of assurance
the supply chain. This move comes in This initiative gains importance regarding the maintenance of proper
response to the increasing threat posed as the Indian pharmaceutical sector drug storage conditions during transit to
by counterfeit and substandard medicines. has come under international scrutiny wholesale and retail levels by manufac-
following accusations linking fake turers.
These new good-distribution practices cough syrups produced in India to the
have been formulated by the DCGI to deaths of children in Gambia, Cameroon, The draft guidelines on good distri-
address the critical challenge of ensur- and Uzbekistan. bution practices have been aligned with
ing product traceability, which has been World Health Organization standards,
hindered by insuffi cient documentation During the DCGI’s drugs consulta- and stakeholders have been given 30
throughout the distribution network, the tive committee meeting in June, it was days to provide their feedback and sug-
report said. The ability to trace products resolved to integrate good distribution gestions before these rules are fi nalised.

SUSTAINABILITY CRITERIA
Syngene secures silver rating in EcoVadis sustainability

index

Syngene International – a global con- refl ects the broad commitment we make tions for clients while respecting the planet
tract research, development and manu- every day to run our business in a respon- and the needs of our communities today
facturing organization (CRDMO) – has sible and sustainable way. The award and for generations to come,” commented
achieved the prestigious silver rating in the refl ects the substantial progress we have Mr. Jonathan Hunt, Managing Direc-
EcoVadis sustainability index, refl ecting made in reducing our environmental foot- tor and CEO, Syngene. The silver rating
its commitment to excellence in Environ- print as well as our strong commitment to refl ects the company’s efforts on all four
mental, Social, and Governance (ESG) good corporate governance. dimensions: 82% renewable energy across
practices. This places the company among all campuses; 96% of waste recycled; 45%
the top 15% of companies assessed world- We are committed to continuing our water recycled or reused; and 70% of total
wide in the past year. efforts, using our scientifi c expertise and procurement is from domestic suppliers
new technology to provide scientifi c solu- in India.
EcoVadis, recognised as a trusted pro-
vider of business sustainability ratings, USFDA issues warning letter to
evaluates companies against 21 sustain- Aurobindo arm
ability criteria under four core themes:
Environment, Labor & Human Rights, A formulation manufacturing faci- from the USFDA. “Subsequent to OAI,
Ethics, and Sustainable Procurement. lity of Eugia Pharma Specialities, a the unit has received a warning letter.
Over 100,000 companies are assessed wholly owned subsidiary of Aurobindo There is no impact on the existing sup-
by EcoVadis every year and the rating Pharma, received a warning letter from plies to the US markets. The company
to Syngene was awarded following a the US Food and Drug Administration remains committed to work closely with
rigorous evaluation. (USFDA). The Hyderabad-based Auro- the USFDA and continues to enhance
bindo, earlier said, the unit III received its compliance on an ongoing basis,” it
“Achieving the EcoVadis silver rating Offi cial Action Indicated (OAI) status informed the stock exchange.

Chemical Weekly August 27, 2024 143

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