Now, Drugs Reg­u­la­tor Gets a Plan for Veg­e­tar­ian Cap­sules

Pro­posal calls for use of cel­lu­lose in­stead of cat­tle-de­rived gela­tine

The Economic Times - - Companies - Divya.Rajagopal @times­group.com

Mum­bai: In­dia’s drug con­troller has said it has re­ceived a pro­posal to bring in veg­e­tar­ian cap­sules in place of gela­tine-based cap­sules, a move that has sur­prised the nearly $1-bil­lion cap­sule in­dus­try. Gela­tine, a key el­e­ment in cap­sules, vi­ta­min drugs and chicken fod­der, is man­u­fac­tured by pro­cess­ing the bones, skin and tis­sue of cat­tle.

“A pro­posal has been re­ceived to re­place gela­tine cap­sules with cel- lu­lose-based cap­sules which are of plant ori­gin and are safe for use as com­pared to an­i­mal-based gela­tine cap­sules,” GN Singh, Drug Con­troller Gen­eral of In­dia (DGCI) wrote in a note. “In or­der to ex­am­ine the pros and cons of the pro­posal, sci­ence-based sug­ges­tions and com­ments are in­vited from the stake­hold­ers... within six weeks,” he said.

The drug con­troller’s move comes just a year af­ter states in­clud­ing Haryana and Ma­ha­rash­tra banned cow slaugh­ter. An email sent by ET to the DCGI of­fice ask­ing about the ra­tio­nale be­hind this sud­den move re­mained unan­swered till Fri­day press time. Al­most 95% of the cap­sules world­wide use gela­tine, ac­cord­ing to Sa­jiv Menon, man­ag­ing di­rec­tor of Nitta Gela­tine, one of the largest man­u­fac­tur­ers in In­dia.

Gela­tine is the stan­dard raw ma­te­rial as per the phar­ma­copoeia in dif­fer­ent coun­tries and is widely ac­cepted and used for man­u­fac­tur­ing of phar­ma­ceu­ti­cal cap­sule shells. How­ever, in­dus­try ex­ec­u­tives said that hy­drox­ypropyl methyl­cel­lu­lose (HPMC) pro­posed by the gov­ern­ment as an al­ter­na­tive, is still not com­pat­i­ble with all drugs.

Ajit Singh, man­ag­ing di­rec­tor of ACG World­wide, one of the largest cap­sule man­u­fac­tur­ers in In­dia, said, the in­dus­try is sur­prised by this move since there is no ques­tion about safety of gela­tine.

“There will be chaos in the pharma in­dus­try.... The ma­chin­ery has to be changed. Also, the cost of veg­e­tar­ian cap­sules is much higher, so prices of drugs may also go up.”

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