Cold Chain Cold Chain in Canada eBook: 2014 | Page 13

Speaker Interview > 3. Abbott India General Manager – Distribution & Logistics What are the keys to successfully shipping pharmaceuticals to India? Generally, when a company exports Pharmaceutical products to another countries there are some important points which should be focused upon - The journey of the product in the right temperature zone and preparedness with the regulatory and statutory compliances of the other country. Same with India. In addition to the maintenance of the requisite cold chain, these regulatory points are important to keep in mind: 1. Registration With DCGI. For any supply of FG or API to India, supplier needs to obtain Registration Certificate with DCGI and Similarly, importer should also obtain import license from DCGI. 2. Labeling Requirement: As per Standards of Weight and measures act 1976. 13 4. Shelf life - Minimum 60% remaining shelf life should be there at the time of import. Packaging and Storage condition for transportation as per requirement. Is there anything particularly different or unique about OPPI standards when it comes to pharmaceuticals? We need to first understand what OPPI is. It is an association of research and innovation driven pharmaceutical companies in India and a scientific and professional body. It is not a government regulatory body. OPPI contrib ]\