Different Storage Conditions and Stability Characteristics for Generics and Innovator Product: Is that allowed?

Different Storage Conditions and Stability Characteristics for Generics and Innovator Product: Is that allowed?

It may happen – in the development of generic medicinal products – that the in-use stability properties or the storage conditions deviate from those of the innovator product. The question whether this is basically allowed or only allowed with restrictions in the context of the application for authorisation of a generic product has been answered by the EMA and put on its updated Q&As webpage. The answer to the following two questions was published as supplement to the Q&As:

  • “Is it allowed that the in-use stability of one product deviates from other authorised products (e.g. regarding storage time, storage conditions)?
  • Is it allowed that the storage condition of one product deviates from other authorised products (e.g. storage in refrigerator versus storage at temperatures not exceeding 25°C)?”

The EMA clearly states in the answer to both questions “each product will be assessed on its own merits”. At the same time, the EMA takes into consideration whether differences in in-use stability and/or storage conditions potentially could lead to detrimental medication errors (wrong dosing). In such a case, the EMA cannot accept the differences and will delay the treatment of the application until the problem has been solved. In its answer, the EMA refers to a position paper of the CHMP which discusses medication errors caused by differences between generics and innovator products. This position paper is dated 30 May 2013 and its title is “Position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measures“. The different in-use stability and storage conditions aren’t explicitly addressed in the document. That’s the reason why the EMA felt compelled to clarify those questions in the Q&As.



DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......http://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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