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Pharmaceuticals


       PROGRESSIVE AMENDMENT
       Animal protection body welcomes IPC’s move to

       waive off animal testing for veterinary vaccines


          The Indian chapter of  animal                                   affi rms  India’s  commitment  towards
       protection  organisation,  Humane                                  eliminating obsolete animal tests for
       Society International (HSI/India), has                             batch release testing of vaccines. We
       welcomed the Indian Pharmacopoeia                                  have been working on this with both
       Commission’s (IPC’s) move to waive                                 IPC and the industry  since  2020 and
       off the  Target  Animal Batch Safety                               we believe that such collaboration is
       Test (TABST) in the Indian Pharma-                                 pivotal in this decision. We look for-
       copoeia, effective 1st July 2024.                                  ward to  facilitating  further advance-
                                                                          ments in other areas of safety testing
          The TABST, a non-specific safety                                of vaccines as well.”
       test for veterinary vaccines, typi-  testing. By recognising the shortfalls
       cally involves the administration of  of the TABST and allowing the test   This waiver follows a series of pro-
       vaccine overdose  to animals  to test  to be waived, India is a step closer  gressive decisions by the IPC. Back in
       that every batch of vaccine produced  to aligning itself with international  2018, the Rabbit Pyrogen  Test was
       is safe for a specific species. How-  veterinary vaccine testing standards,  replaced with the Bacterial Endotoxin
       ever, multiple studies have proved  joining Brazil, Europe, Canada, the  Test (BET), followed by the inclu-
       that the method lacks specificity  US, Japan, and others,” HSI/India  sion of the Monocyte Activation Test
       and is prone to producing false re-  said in a statement.          in 2018 and removal of the Abnormal
       sults. “The IPC’s decision to waive                                Toxicity  Test for almost all human
       the  TABST will reduce the number   Ms.  Alokparna Sengupta, Man-  vaccines in 2020 from Indian Pharma-
       of animals subjected to unnecessary  aging Director at HSI/India said, “re-  copoeia monographs.
       Suraj Laboratories’ R&D facility gets DSIR


       recognition


          Hyderabad-based  pharma  fi rm,
       Suraj  Laboratories,  has announced
       that  its in-house R&D unit located  in
       Hyderabad (Telangana)  has received
       prestigious recognition  from the
       Department of Scientifi c and Industrial
       Research (DSIR), Ministry of Science
       and Technology.

          The recognition  will entitle  the
       R&D unit to avail  customs/central  innovative work, including development  at Kadechur, Karnataka. “The collabo-
       excise duty exemption on the purchase/  of new products, design and engineer-  ration between Lamoral and Neochem
       import of equipment, instruments,  ing, and process/product/design im-  Technologies represents a powerful syn-
       spares, consumables etc for its activi-  provements.               ergy. By combining Lamoral’s innova-
       ties. The registration is valid up to 31                           tion, global reach and technical prowess
       March 2027, the company informed.   Suraj Laboratories, which offers  with Neochem’s agility, local expertise
                                         generic Active Pharmaceutical Ingredients  and innovative spirit, we aim to create
          The DSIR  recognition is  accord-  (APIs) and saleable intermediates for  unparalleled value for our customers and
       ed to in-house R&D units engaged in  APIs, operates a manufacturing plant  partners,” the press note informed.

       144                                                                      Chemical Weekly  July 30, 2024


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