Page 144 - CW E-Magazine (24-12-2024)
P. 144

Top Stories                                                                                                                                                                    Pharmaceuticals


       THE WAY FORWARD                                                                                               QUALITY CONTROL

       India’s transition to circular economy requires                                                               Aurobindo, Glenmark, Zydus recall products in US

       collective action; R&D, industry collaboration important:                                                     over manufacturing issues

       Amitabh Kant                                                                                                     Drug  makers  Aurobindo  Pharma,                                 are  used  to  treat  high  blood  pressure.
         “India’s  transition  to  a  circular                            India,  CEEW,  and  RMI  explores  the     Glenmark  and  Zydus  are  recalling                                The  company  initiated  the  Class  II
       economy is not the responsibility of any                           immense  potential  of  circularity  spans   products in the US market due to manu-                            nationwide (US) recall on November 1
       single stakeholder. It requires collective                         across sectors, from transforming agri-    facturing  issues,  according  to  the  US                          this year.
       action,  deliberate  and  coordinated                              cultural waste into value-added products   health regulator.
       effort across industries, and must be driven                       to optimising resource use in construc-                                                                           The  USFDA  further  stated  that
       by  R&D,”  said  Mr.  Amitabh  Kant,                               tion amidst accelerating urbanisation”.       As  per  the  latest  Enforcement                                Zydus  Pharmaceuticals  (USA)  Inc.  is
       G20  Sherpa  for  India,  at  the  launch                                                                     Report of US Food and Drug Administra-                              recalling 4,404 packs of Esomeprazole
       of  a  collaborative  discussion  paper,                              Ms.  Ghate  added,  “This  is  not      tion (USFDA), Aurobindo Pharma USA                                  Magnesium  for  Delayed-Release  Oral
       ‘Unlocking  India’s  Circular  Economy                             merely  a  call  to  recycle  but  a  call  to   Inc., a subsidiary of Hyderabad-based   Similarly,  a  US-based  subsidiary  Suspension (40-mg) due to a labelling
       Potential:  Insights  Across  Seven  Key                           reimagine  systems, foster resilience,     drug  maker,  is  recalling  over  1-lakh  of  Glenmark  Pharmaceuticals  is  re-  error.  The  medication  is  used  to  treat
       Sectors’, in New Delhi recently. The paper                         and create new value across industries.    bottles of Cinacalcet tablets in multiple  calling around 90,000 bottles of Dilti-  certain  stomach  and  oesophagus  pro-
       was launched at a session hosted by the                            RMI, along with CEEW and WRI India,        strengths. The New Jersey-based fi rm is  azem  Hydrochloride  extended-release  blems.  The  company  initiated  the
       World  Resources  Institute  (WRI)  India,  To achieve this, we must work collectively –  through this discussion paper has made   recalling the product due to “GMP De-  capsules (multiple strengths) in the US  nationwide recall of the affected packs
       Rocky Mountain Institute (RMI), and  government, industry, think tanks, and  an  attempt  to  highlight  the  power  of   viations:  Presence  of  N-nitroso  Cina-  market.  Glenmark  Pharmaceuticals  on November 14.
       the  Council  on  Energy,  Environment  civil  society  –  to  build  an  ecosystem  collective action.”      calcet  impurity  above  FDA  recom-  Inc., USA is recalling the affected lot
       and  Water  (CEEW).  The  paper  pro-  that embeds circularity at scale.”                                     mended  interim  limit,”  the  US  health  of  Diltiazem  Hydrochloride  extended-  As per the USFDA, a Class II recall
       vides  actionable  recommendations  to                                Dr. Ghosh, said, “The circular eco-     regulator said.                   release  capsules  due  to  “cGMP  Devi-  is initiated in a situation in which the
       advance  circularity  in  sectors  includ-  Leading  voices  from  the  govern-  nomy  is  not  just  about  recycling;  it’s                   ations:  Presence  of  N-nitroso-Desme-  use of, or exposure to, a violative pro-
       ing solar, batteries, steel, construction,  ment, academia, and industry, such as  about  rethinking  how  we  design,  use,   The company initiated the Class II  thyl-Diltiazem  impurity  above  FDA  duct may cause temporary or medically
       agriculture, wastewater, and municipal  Mr.  Sree  Kumar  Kumaraswamy  (Pro-  and repurpose resources. It’s crucial for   recall on November 7 this year. Cina-  recommended interim limit”, the US  reversible  adverse  health  consequences
       solid waste.                      gram Director – Clean Air Action, WRI  our  sustainable  development,  energy   calcet  tablets  are  used  to  treat  hyper-  health regulator stated. Diltiazem Hydro-  or  where  the  probability  of  serious
                                         India),  Ms.  Akshima  Ghate  (Managing  security,  and  climate  action  goals. As   parathyroidism.         chloride  extended-release  capsules  adverse health consequences is remote.
         In  his  keynote  speech,  Mr.  Kant  Director,  RMI),  and  Dr.  Arunabha  Indians, we know waste can be wealth.
       said, “Circular economy offers a really  Ghosh  (CEO,  CEEW)  also  came  It’s time to unlock its business oppor-  Lupin acquires 3 anti-diabetes trademarks
       compelling solution to the dilemma that  together  for  a  panel  discussion  at  the  tunity – from steel to silicon to sludge.”
       India  is  facing  of  urbanisation  and  session  to  deliberate  on  the  practical                         from Boehringer Ingelheim
       industrialisation. India’s vibrant startup  steps needed to embed circularity into   The  paper  calls  for  investment  in
       ecosystem and digital advancements  India’s economic fabric.       advanced recycling technologies to im-        Lupin  has  acquired  anti-diabetes
       position  us  uniquely  to  revolutionise                          prove material recovery rates and reduce   trademarks Gibtulio, Gibtulio Met and
       resource  management  and  accelerate   Mr. Madhav Pai, CEO, WRI India,  reliance on virgin resources. The deve-  Ajaduo  from  Boehringer  Ingelheim
       the  transition  to  a  circular  economy.  said,  “The  discussion  paper  by  WRI  lopment  of  cohesive  policy  and  regula-  International, strengthening its diabetes
                                                                          tory  frameworks,  such  as  Extended      footprint in the country.
                                                                          Producer  Responsibility  and  Circular
                                                                          Product Design Standards, is also vital to    The trademark  rights for these
                                                                          incentivising waste reduction and reuse.   brands will be transferred to Lupin by
                                                                          Further,  building  robust  infrastructure   March  next  year,  Lupin  said,  without
                                                                          for  waste  collection  and  recycling,  es-  giving fi nancial details.
                                                                          pecially  in  underserved  regions,  will                                       Gibtulio  (empaglifl ozin),  Gibtulio  with  diet  and  exercise,  the  company
                                                                          ensure  that  materials  are  effi ciently     Lupin  has  been  marketing  Gib-  Met (empaglifl ozin + metformin), and  said. Empaglifl ozin is also indicated to
                                                                          recovered and reused. These measures,      tulio and  Gibtulio  Met  since  2016  Ajaduo  (empaglifl ozin  +  linagliptin)  reduce the risk of cardiovascular death
                                                                          coupled with collaboration across govern-  and  Ajaduo  since  2018  in  the  Indian  belong  to  a  novel  class  of  oral  anti-  in adults with type-2 diabetes, and the
                                                                          ment, industry, and civil society, could   market  through  existing  co-marketing  diabetic  drugs,  that  are  indicated  to  risk of cardiovascular death and hospi-
                                                                          unlock signifi cant economic value while    agreements with Boehringer Ingelheim  improve  glycaemic  control  in  adults  talisation for heart failure in adults with
                                                                          mitigating environmental harm.             India.                            with  type-2  diabetes  mellitus,  along  chronic kidney disease, the note said.

       144                                                                 Chemical Weekly  December 24, 2024        Chemical Weekly  December 24, 2024                                                              145


                                      Contents    Index to Advertisers    Index to Products Advertised
   139   140   141   142   143   144   145   146   147   148   149