DCGI Mulls Al­ter­na­tives to China APIs

Asks pharma cos to chalk out emer­gency plans in case raw ma­te­ri­als get blocked

The Economic Times - - Companies: Pursuit Of Profit -

Divya Ra­jagopal & Prabha Ragha­van

Mum­bai: The Drug Con­troller Gen­eral of In­dia (DCGI) has got lo­cal drug mak­ers to draw up an emer­gency plan on deal­ing with any block­ade on ship­ments from China of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (APIs), or raw ma­te­ri­als used to make medicines in the event of bor­der ten­sions es­ca­lat­ing. In­dian com­pa­nies get most of their APIs from China.

A meet­ing last month had dis­cussed the mat­ter, said a se­nior gov­ern­ment of­fi­cial.

“The gov­ern­ment has iden­ti­fied im­por­tant ther­a­peu­tic seg­ments for which mol­e­cules are (mostly) im­ported (from China),” said the of­fi­cial. The meet­ing was at­tended by var­i­ous in­dus­try as­so­ci­a­tion groups of both multi­na­tional and In­dian drug mak­ers. “The agenda of the meet­ing was to un­der­stand what mea­sures the gov­ern­ment could take to sup­port the do­mes­tic in­dus­try and en­cour­age it to man­u­fac­ture these prod­ucts.” The In­dian Drug Man­u­fac­tur­ers’ As­so­ci­a­tion (IDMA), a lobby group of do­mes­tic pharma com­pa­nies, re­cently sub­mit­ted a six-page ac­tion plan that lists var­i­ous mea­sures that the In­dian gov­ern­ment should im­ple­ment to re­duce de­pen­dence on APIs from China. ET has seen a copy of this.

This in­cludes higher reg­is­tra­tion fees on im­ports and in­creased in­spec­tions of APIs from China. It has also asked the gov­ern­ment to ex­plore al­ter­na­tive sources for raw ma­te­ri­als, es­pe­cially es­sen­tial ther­a­pies such as anti-in­fec­tive drugs. Ad­di­tion­ally, it has sug­gested the re­vival of state-run units such as Hin­dus­tan An­tibi­otics that can pro­duce es­sen­tial raw ma­te­ri­als in an emer­gency.

“At present, In­dia is not able to man­u­fac­ture many im­por­tant drugs due to low-priced im­ports from China. In order to be ready for any fu­ture emer­gency, we need to have at least some ca­pac­i­ties cre­ated for a few of the drugs which are iden­ti­fied as es­sen­tial for the coun­try. In this way, in case of any emer­gency, all that we need to do is in­crease ca­pac­ity of the same in a short time,” IDMA said in the let­ter to the drug con­troller. “We should fur­ther en­sure that com­pa­nies are ad­vised to main­tain three-six months stock of APIs/in­ter­me­di­ates that are im­ported from China.” There was no re­sponse to emails sent to DGCI on Mon­day. IDMA didn’t re­spond to queries.

In­dia im­ports about 84% of the APIs it needs, ac­cord­ing to of­fi­cials in the Cen­tral Drugs and Stan­dards Con­trol Or­gan­i­sa­tion (CDSCO). It got APIs worth ₹ 13,853 crore from China in FY16, or 65.3% of the ₹ 21,217 crore to­tal. This in­cluded in­gre­di­ents for es­sen­tial an­tibi­otics. The value of Chi­nese API im­ports, ac­cord­ing to DCGI, is ₹ 8,000-10,000 crore in the In­dian for­mu­la­tions mar­ket, which is es­ti­mated at ₹ 1 lakh crore by the in­dus­try.

In­dus­try groups have sug­gested that the gov­ern­ment en­ter into agree­ments with friendly na­tions for the sup­ply of key medicines and APIs in the cat­e­gories spec­i­fied above.

“There is a con­cern that if the ten­sions con­tinue over the bor­der is­sue, this will hit pharma sec­tor and it is wor­ry­ing be­cause we do not

even have the API ca­pac­ity to man­u­fac­ture a parac­eta­mol,” said an ex­ec­u­tive who was at the meet­ing men­tioned above. “But be­cause In­dian com­pa­nies do not have any sup­port from the gov­ern­ment to pro­duce APIs we are los­ing out to China.”

Though In­dia is a leader in fin­ished generic drugs, China is a pre­ferred source for APIs be­cause of price. The re­newed Make in In­dia push for APIs stems from the trade deficit of about $53 bil­lion with China. Also, In­dia’s re­peated re­quests for in­creased mar­ket ac­cess in sec­tors such as phar­ma­ceu­ti­cals and soft­ware have so far yielded lit­tle re­sult. Last week Chi­nese drug maker Fo­sun said it had ex­tended the dead­line for clos­ing the $1-bil­lion ac­qui­si­tion of In­dian drug maker Gland Pharma as it is yet to re­ceive the ap­proval of In­dia’s cab­i­net com­mit­tee on eco­nomic af­fairs. There’s been spec­u­la­tion that the bor­der dis­pute may be a fac­tor in this.

“I feel that nor­mal macro trade might con­tinue. How­ever, it is the non­tra­di­tional sec­tors, the new emerg­ing ar­eas — the new op­por­tu­ni­ties which would have im­proved the over­all trade balance — and in­vest­ments that might take a hit,” said Alka Acharya, di­rec­tor of In­sti­tute of Chi­nese Stud­ies, New Delhi. “We are in fact look­ing at the be­gin­nings of the un­rav­el­ing of the con­fi­dence that busi­ness and com­merce that would pro­vide the badly needed bal­last to this re­la­tion­ship.”

Par­lia­ment was in­formed last Au­gust that the Na­tional Se­cu­rity Ad­vi­sor had warned the gov­ern­ment about over-de­pen­dence on the neigh­bour­ing coun­try in the sup­ply of es­sen­tial drugs and APIs. To en­cour­age do­mes­tic pro­duc­tion of bulk drugs, the gov­ern­ment no­ti­fied the with­drawal of cus­toms duty ex­emp­tions for cer­tain cat­e­gories of drugs and bulk drugs on Jan­uary 28 last year.

The Prime Min­is­ter’s Of­fice had in­structed the Niti Aayog along with the min­istries of health, com­merce and in­dus­try, and chem­i­cals and fer­tilis­ers to draw up a com­pre­hen­sive plan to pro­duce APIs in In­dia. DCGI was also told to set up a reg­u­la­tory of­fice in China to bet­ter mon­i­tor the qual­ity of prod­ucts en­ter­ing In­dia. The rest of In­dia’s API im­ports come from Euro­pean coun­tries, par­tic­u­larly Italy.

IDMA has sought higher reg­is­tra­tion fees on im­ports and in­creased in­spec­tions of APIs from China

Newspapers in English

Newspapers from India

© PressReader. All rights reserved.