Page 2 - Guidance document for import of Drugs & Pharmaceuticals from India
P. 2
INDIAN POLITICAL SYSTEM
India is a democratic Republic country following federal system of ruling.
There are 29 States (Provinces) 7 Union Territories and in the country. As per
principles of Federal System, legislative powers are divided into three parts i.e.
Union list, States list and Concurrent lists. While healthcare comes under
States list, Drugs regulatory subject comes under Concurrent list. Thus
manufacture, sale/distribution, export/import of food and drugs in India are
regulated by both State / (Province) and Central Governments.
INDIAN PHARMA INDUSTRY
Indian Pharma Industry is one of key players in Indian economy contributing
about US$ 15 bn to the foreign exchange revenue in 2013-14. Domestic
industry is also valued at about US$ 15 bn. During 2012-13 and 13-14, exports
of Drugs & Pharmaceuticals have occupied Fifth place in the exported principal
commodity of the country accounting for 4.83% of India’s total exports. Indian
Pharma companies have quality accreditations from all major regulated
markets. Over 500 manufacturing sites are approved by US FDA and over 350
sites are approved by EDQM Europe. UK MHRA issued about 1100 marketing
authorizations Indian companies. Over 1500 Indian manufacturing plants are
having WHO GMP certifications. More than 55% of Indian pharma exports are
to the regulated markets.
India is a democratic Republic country following federal system of ruling.
There are 29 States (Provinces) 7 Union Territories and in the country. As per
principles of Federal System, legislative powers are divided into three parts i.e.
Union list, States list and Concurrent lists. While healthcare comes under
States list, Drugs regulatory subject comes under Concurrent list. Thus
manufacture, sale/distribution, export/import of food and drugs in India are
regulated by both State / (Province) and Central Governments.
INDIAN PHARMA INDUSTRY
Indian Pharma Industry is one of key players in Indian economy contributing
about US$ 15 bn to the foreign exchange revenue in 2013-14. Domestic
industry is also valued at about US$ 15 bn. During 2012-13 and 13-14, exports
of Drugs & Pharmaceuticals have occupied Fifth place in the exported principal
commodity of the country accounting for 4.83% of India’s total exports. Indian
Pharma companies have quality accreditations from all major regulated
markets. Over 500 manufacturing sites are approved by US FDA and over 350
sites are approved by EDQM Europe. UK MHRA issued about 1100 marketing
authorizations Indian companies. Over 1500 Indian manufacturing plants are
having WHO GMP certifications. More than 55% of Indian pharma exports are
to the regulated markets.
