Govt to bar private lab tests of vac­cines, bio­lo­gical products

India plans to restrict the test­ing of vac­cines and spe­cial­ized bio­lo­gical products exclus­ively to gov­ern­ment­ con­trolled labor­at­or­ies to main­tain qual­ity stand­ards, accord­ing to two gov­ern­ment offi­cials and doc­u­ments reviewed by Mint. The new approach will affect private labor­at­ory oper­at­ors and the phar­ma­ceut­ical man­u­fac­tur­ers that rely on them for faster test­ing turn­around times.
Cur­rently, private labs are allowed to test spe­cified drugs includ­ing vac­cines and bio­lo­gic­als. However, the Cent­ral Drugs Stand­ard Con­trol Organ­isa­tion (CDSCO) is now plan­ning a major policy shift, and took up the mat­ter for dis­cus­sion at a drugs con­sultat­ive com­mit­tee meet­ing last month.
“The CDSCO believes that the spe­cial­ized nature of vac­cines war­rants a more restrict­ive test­ing envir­on­ment. Another object­ive is also to bring uni­form­ity across all test­ing plat­forms,” one gov­ern­ment offi­cial said, request­ing anonym­ity. “The new policy in the works would man­date that man­u­fac­tur­ers of bio­lo­gical
products route their batch test­ing through author­ized gov­ern­ment insti­tu­tions like the National Insti­tute of Bio­lo­gic­als based in Noida, effect­ively de-author­iz­ing private labs for this spe­cific cat­egory of medi­cines.”
Cur­rently, the Drugs and Cos­metic Rules, 1945, has pro­vi­sions for the approval of stan­dalone private labor­at­or­ies to test the iden­tity, pur­ity, qual­ity and strength of drugs and raw mater­i­als on behalf of licensed man­u­fac­tur­ers.
There are seven Cent­ral Drug Test­ing Labor­at­or­ies and 36 state drug test­ing labor­at­or­ies across India.
Source : Pressreader