India is having very huge pharmaceutical industry chain, as they have team of expertise, technology and a very good quality of medicines here.
Indian pharmaceutical manufacturing companies are growing very fast as they have already entered in export market of various countries in world.
In India export marketing of pharmaceutical products are very profitable as they are the 3rd higher number of producer of pharmaceutical products in all the dosage forms like tablets, hard gelatin capsules, soft gelatin capsules liquid syrups, dry syrups, liquid injections, lyophilized injections, sachets, cream, ointments, soap, shampoo, etc.
But before starting exports business in different countries, pharmaceutical companies have to follow the drug regulations and guidelines of respective countries. Pharmaceutical companies have to maintain all the standards at the higher level to fulfil the demands of export market of different countries.
For pharmaceutical product registration in different countries, there is a requirement of dossiers.
Dossiers are the compilation of the required documents related to the product to be registered.
Types of Dossiers
Common technical documents (CTD) format
Asean common technical documents (ACTD) format
Country specific (this is based on regional format)
All the regulated countries and some semi-regulated countries follow the CTD format of dossiers.
Whereas some semi-regulated and some non-regulated countries as well as ASEAN countries like Cambodia, Singapore, Thailand, Malaysia, Philippines, Myanmar etc follows the ACTD format of dossiers.
Rest of countries follow their regional format of dossiers which is country specific.
Many pharmaceutical companies like Affy group is introducing their business to export market. As they are the pharmaceutical exporter, manufacturer and supplier in India. They have already their footprints in several countries ASEAN countries like Philippines, Cambodia etc and CIS countries like Uzbekistan etc, Ivory coast and French west African region.