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CSR INITIATIVE QUALITY ISSUES

ABB India supports educational programmes in 148 Dr. Reddy’s, Sun Pharma recall drugs in US market

government schools in Karnataka Dr. Reddy’s Laboratories and Sun company initiated the Class II nation-
Pharma are recalling products in the US wide (US) recall on June 7, 2024, the
ABB India has announced the expan- due to manufacturing issues, as per US health regulator said. The USFDA
sion of two educational programmes as the latest Enforcement Report by the said a US-based unit of Sun Pharma
part of its Corporate Social Responsibility US Food and Drug Administration is recalling 2,088 vials of Decitabine
(CSR) initiatives to support inclusive and (USFDA). for Injection (50-mg per vial) due to
equitable education. These programmes, “cGMP deviations”. The affected lot of
which were being run in 98 schools in According to the report, Dr. Reddy’s the chemotherapy medication was pro-
Nelamangala, will now also expand to 50 is recalling drugs to treat insomnia The company issued the Class III duced at Sun Pharma’s Gujarat-based
schools in Peenya starting this academic and gout in the American market. New nationwide recall on June 4 this year. manufacturing plant. New Jersey-based
year, reaching a total of 148 schools and Jersey-based Dr. Reddy’s Laboratories, As per the USFDA, a Class III recall is Sun Pharmaceutical Industries initi-
around 10,000 students from Peenya and Inc., a unit of Hyderabad-based drug initiated in a “situation in which use of, ated the nationwide Class II recall on
Nelamangala. major, is recalling 13,752 bottles of or exposure to, a violative product is July 2 this year. As per the USFDA, a
Eszopiclone tablets, the USFDA stated. not likely to cause adverse health con- Class II recall is initiated in a situation
The STEM Awareness and Foun- The affected lot has been produced sequences”. in which the use of, or exposure to, a
dational Literacy and Numerical Skills at Dr. Reddy’s Bachupally plant in violative product may cause temporary
Program is aimed at supporting young Telangana. As per the USFDA, the drug Dr. Reddy’s Laboratories, Inc. is or medically reversible adverse health
students with essential scientifi c con- Representatives from ABB India, Shikshana Foundation and Government of Karnataka fi rm is recalling the affected lot due to also recalling 20,520 units of Allopu- consequences or where the probability
cepts and foundational and age-appro- at the STEM and FLN Program Inauguration “Failed impurities/degradation specifi - rinol tablets in the US market due to the of serious adverse health consequences
priate skills in literacy and numeracy the programme aims to equip primary tion with the Centre for Environment cations”. “presence of foreign substance”. The is remote.
alongside STEM topics. Integrated and higher primary students with the Education (CEE). It aims to prepare
within the school timetable, it provides much-needed competencies essential higher primary school students to face Biocon Biologics receives approval from EMA
hands-on learning opportunities, making for their cognitive development. Parya- environmental sustainability challenges
learning interactive and engaging. Run varan Mitra, the other programme, will by engaging them in eco-friendly activi- to manufacture biosimilar, Bevacizumab
in partnership with Sikshana Foundation, be launched soon, and run in collabora- ties in schools and its surroundings.
LIVELIHOOD GENERATION Biocon Biologics, the biosimilars EMA coordinates these inspections to The facility has previously been
subsidiary of Biocon Ltd., has received verify that a medicine manufacturer approved to manufacture biosimilar,
CSIR and M.S. Swaminathan Research Foundation approval from European Medicines complies to these minimum standards. Trastuzumab, in September 2022.
Agency (EMA) to manufacture biosimi-
to focus on rural development lar, Bevacizumab, a type of targeted can- Sanofi India puts Mumbai head-
cer drug treatment at its new multi-pro-
The Council of Scientifi c and Speaking on the occasion, Dr. Kalai- duct monoclonal antibodies (mAbs) drug quarters on the block
Industrial Research (CSIR) and the selvi, stated that although CSIR labs substance facility at Bengaluru. This
M.S. Swaminathan Research Foundation disseminate technologies developed in approval will provide signifi cant addi- French pharmaceutical company of other operations. In May 2023, the
(MSSRF) have entered an MoU to work the labs to potential users, the outreach, tional capacity to address patients’ needs Sanofi ’s Indian arm has decided to put company’s board of directors decided
together for livelihood generation among especially in the societal sector, would be across markets in Europe. the standalone property spread over to demerge its consumer health business
rural, tribal, and farming communities. greatly enhanced by joining hands with 150,000 sq ft that houses its country into a separate legal entity, to allow it to
organisations such as MSSRF that work The company announced that EMA headquarter in Mumbai’s Powai loca- have independence to pursue its growth
The MoU was signed by Dr. N. Kalai- at the grassroots level. Dr. Swaminathan has renewed its Good Manufacturing lity on the block, a Reuters report said strategies and this was approved by the
selvi, Director General, CSIR and stated that MSSRF is seeking select low- Practice (GMP) Certifi cates of Com- quoting unnamed sources. shareholders in December. The National
Dr. Soumya Swaminathan, Chairperson, cost and affordable technologies. Tri- pliance for its biosimilars manufactur- Company Law Tribunal, Mumbai, fol-
MSSRF. Senior offi cials from CSIR and bals and various other such groups, she ing facility at Bengaluru and its insulin The company has already picked up lowing a hearing, sanctioned the de-
representatives of MSSRF witnessed the across the CSIR labs and mentoring the added, are not able to directly approach facility in Malaysia following routine an offi ce in Vikhroli suburb through a merger in May 2024, paving the way for
signing of the MoU. The MoU entails SHGs/NGOs/FPOs and other voluntary CSIR labs due to many reasons includ- GMP inspections. Good manufacturing long-term lease to shift one of its divi- the listing of the new separate company,
creating a framework for the transfer of organisations selected by MSSRF for ing geographical location, communi- practice describes the minimum stand- sions Sanofi Consumer Healthcare and Sanofi Consumer Healthcare Ltd. This
affordable, proven and selected techno- livelihood generation and empowerment cation challenges and lack of required ard that a medicine manufacturer must is in the process of leasing additional demerged entity will operate from the
logies with societal relevance available of women, tribal population. resources. meet in their production processes. The space for growth as well as relocation newly leased Vikhroli offi ce premise.

148 Chemical Weekly July 23, 2024 Chemical Weekly July 23, 2024 149

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