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India by M M with CC

Today, India is among the top five phar­ma­ceu­ti­cal Emerg­ing Mar­kets in the world. While India ranks tenth glob­ally in terms of market value, it is ranked third in vol­ume. The mar­ket is expected to grow at a CAGR of 14–17% between 2013 and 2016. Generic brands dom­i­nate and con­sti­tute around 70-80% of the retail mar­ket.

Local play­ers have enjoyed a dom­i­nant posi­tion in India, dri­ven by devel­op­ment oppor­tu­ni­ties and early invest­ments. Price lev­els are low due to intense com­pe­ti­tion. Indian OTC and Pharma com­pa­nies have a rep­u­ta­tion for pro­duc­ing high-qual­ity generic med­i­cines that are sold around the world.

Speak­ing of dis­tri­b­u­tion, India relies on a clear­ing and for­ward­ing agent (CFA) sys­tem. While the num­ber of dis­trib­u­tors and retail phar­ma­cies is always increas­ing, there are still inefficiencies in dis­tri­b­u­tion, par­tic­u­larly in rural areas. The main cus­tomers are phar­ma­cies (70%) and hos­pi­tals (30%). Set to witness the largest number of mergers and acquisitions in the pharmaceutical and healthcare industry, India is poised to become one of the fastest-grow­ing phar­ma­ceu­ti­cal mar­kets in the world. A sur­vey con­ducted across 100 com­pa­nies has revealed that one quar­ter of respon­dents were opti­mistic about India’s potential for acqui­si­tions in the phar­ma­ceu­ti­cal sec­tor in the com­ing years.

The top Indian phar­ma­ceu­ti­cal man­u­fac­tur­ers are J.B. Chem­i­cals, Cipla and Sun Pharma. The Indian reg­u­la­tor of phar­ma­ceu­ti­cals is the Cen­tral Drug Stan­dards Con­trol Orga­ni­za­tion (CDSCO). Depend­ing on the type of prod­uct, drugs need to first go through a new drug approval in order to be reg­is­tered. For drugs that have never been mar­keted in India before, the CDSCO typ­i­cally requires phase III tri­als to be per­formed in India. Afterwards, an import reg­is­tra­tion certificate can be attained, which the import­ing party uses to obtain an import licence from the CDSCO.

CPC Press Releases on India:

China and India: Big opportunities…or big risks, or…?