India to intro­duce new regime to track bulk drug products

Facing mount­ing scru­tiny over drug safety lapses, India is work­ing to over­haul its phar­ma­ceut­ical licens­ing frame­work by intro­du­cing a sep­ar­ate whole­sale licens­ing regime for bulk drugs, act­ive phar­ma­ceut­ical ingredi­ents (APIS) and key start­ing mater­i­als (KSMS), accord­ing to three gov­ern­ment offi­cials and doc­u­ments reviewed by Mint.
A draft noti­fic­a­tion is in the works for a new licens­ing regime, the people cited above said on the con­di­tion of anonym­ity. This will dis­mantle the cur­rent com­mon licens­ing sys­tem for raw mater­i­als and fin­ished medi­cines, give the Drugs Con­trol­ler Gen­eral of India (DCGI) a long-miss­ing registry of nearly 1.2 mil­lion bulk drug traders, and sig­ni­fic­antly strengthen trace­ab­il­ity and account­ab­il­ity in the coun­try’s phar­ma­ceut­ical mar­ket.
“The lack of trans­par­ency in the raw mater­ial sup­ply chain was high­lighted by recent reports of cough syr­ups con­tam­in­ated with diethyl­ene glycol, rais­ing ser­i­ous safety con­cerns. It is the need of the hour to mon­itor the sup­ply chain and the qual­ity of high-risk solvents, includ­ing pro­pyl­ene glycol used in for­mu­la­tions,” said one of the three offi­cials said on the con­di­tion of anonym­ity.
The pro­posed change aims to build a com­pre­hens­ive data­base of bulk drug traders, improve trace­ab­il­ity of impor­ted raw mater­i­als, over 70% of which come from China, and allow reg­u­lat­ors to quickly identify and hold account­able spe­cific deal­ers involved in the sup­ply of sub­stand­ard inputs in India’s $50-bil­lion phar­ma­ceut­ical mar­ket.
The mar­ket for APIS, bulk drugs and advanced inter­me­di­ates, was val­ued at approx­im­ately $3.5 bil­lion in FY25.
The gov­ern­ment move comes in the back­drop of India’s repu­ta­tion as the ‘Phar­macy of the World’ tak­ing a hit due to deaths of chil­dren in Uzbek­istan, Gam­bia, Cameroon and India linked to cough syr­ups man­u­fac­tured by Indian firms.
While the total value for India’s total phar­ma­ceut­ical-related imports—includ­ing fin­ished products—for FY24 was approx­im­ately $8.2 bil­lion, bulk drugs remain the dom­in­ant share of this inflow data from the Dir­ect­or­ate Gen­eral of Com­mer­cial Intel­li­gence and Stat­ist­ics and com­merce min­istry shows.
India’s API mar­ket is pro­jec­ted to reach $38.13 bil­lion by 2034, grow­ing at a CAGR of 8.50% from 2025 to 2034, accord­ing to reports by research firms like Mar­ket Research Future.
Source : Pressreader