Man­u­fac­tur­ing firms of phar­ma­ceu­ti­cal need to com­ply with the nec­es­sary reg­u­la­tory pro­vi­sion

Bhutan Times - - Home - Sonam Pen­jor

As the man­u­fac­tur­ing firms of phar­ma­ceu­ti­cal need to com­ply with the nec­es­sary reg­u­la­tory pro­vi­sion while man­u­fac­tur­ing but to com­ply with this the firm’s faces chal­lenges while go­ing ac­cord­ingly. Those is­sues were raised dur­ing the Good Man­u­fac­tur­ing Prac­tices (GMP) work­shop for the man­u­fac­tur­ing per­son­nel at Phuentshol­ing.

The is­sues were, for in­stance, the firms re­quire sep­a­rate im­port au­tho­riza­tion for ev­ery sin­gle prod­uct, va­lid­ity tech­ni­cal au­tho­riza­tion and also for tax ex­emp­tion on im­port of raw ma­te­rial for pro­duc­tions of APIs and for those plants and ma­chiner­ies used in the phar­ma­ceu­ti­cal plants.

Dy. Chief Reg­u­la­tory Of­fi­cer, Ngawang Dema from Drug Reg­u­la­tory Author­ity said that as per Bhutan Medicines Rules and Reg­u­la­tion, 2012, im­port au­tho­riza­tion is re­quired for all the medic­i­nal prod­ucts to en­sure that only qual- ity or reg­is­tered prod­ucts are be­ing im­ported from au­then­ti­cated source.

She added that some ingredients are listed in­ter­na­tion­ally as pre­cur­sor chem­i­cals for il­licit man­u­fac­ture of drugs and this re­quires ad­di­tional im­port per­mit from Bhutan Nar­cotic Con­trol Author­ity. Some medic­i­nal prod­ucts are banned for im­port due to health haz­ards.

One time blan­ket ap­proval may com­pro­mise on the sur­veil­lance as­pects of reg­u­la­tory func­tions. How­ever, reg­u­la­tory pro­vi­sion re­quir­ing im­port au­tho­riza­tion for raw ma­te­ri­als which do not fall un­der the re­stricted cat­e­gory for man­u­fac­tur­ing of medic­i­nal prod­ucts in the coun­try maybe re-vis­ited and dis­cussed as rec­om­mended by our client, she added.

With the launch­ing of G2C sys­tem, the is­suance of im­port au­tho­riza­tion is also do­ing through on­line sys­tem but the author­ity faces chal­lenges with tech­ni­cal, she said that they have tried from this year to op­er­a­tional­ize the on­line sys­tem through sup­port of G2C, but there are tech­ni­cal prob­lems as­so­ci­ated with it be­cause on­line process was tak­ing longer than the rou­tine man­ual one. Hence, this sys­tem is un­der process of re­view and rec­ti­fi­ca­tion.

How­ever, she added that through emails, ap­pli­ca­tions are en­ter­tained and scanned copies of au­tho­riza­tions are dis­patched.

For the va­lid­ity of the tech­ni­cal au­tho­riza­tion, free sale cer­tifi­cate and ex­port au­tho­riza­tion is very short and ex­pire early, so she said that the va­lid­ity of techni- cal au­tho­riza­tion is for one year in line with the va­lid­ity of trade li­censes. Other doc­u­ments such as free sale cer­tifi­cate, ex­port au­tho­riza­tions are from three months to six months.

“We have plans to amend the Medicines Rules and Reg­u­la­tion in con­sul­ta­tion with our stake­hold­ers keep­ing in mind of DRA’s vi­sion as dy­namic, re­li­able and client-cen­tric or­ga­ni­za­tion,” said Ngawang Dema.

Cur­rently, the firms were im­posed taxes for im­port of raw ma­te­rial. The is­sue was raised by the man­u­fac­tur­ing firms for ex­emp­tion of taxes but Ngawang Dema said that ex­emp­tion of taxes is not di­rectly un­der the purview of DRA’s ju­ris­dic­tion; how­ever, she added that they have agreed to dis­cuss this is­sue with the rel­e­vant agen­cies such as Min­istry of Fi­nance and Min­istry of Eco­nomic Af­fairs in a way of pro­mot­ing do­mes­tic man­u­fac­tur­ers for Phar­ma­ceu­ti­cals.

Mean­while, the GMP Work­shop was aimed to pro­mote reg­u­la­tory com­pli­ances and also to dis­cuss on the reg­u­la­tory pro­vi­sions un­rea­son­ably de­ter­ring the growth of their busi­ness.

The work­shop on ba­sic Prin­ci­ples of Good Man­u­fac­tur­ing Prac­tices (GMP) was at­tended by 23 key per­son­nel from var­i­ous man­u­fac­tur­ing firms such as Ac­tive Phar­ma­ceu­ti­cals Ingredients, Med­i­cal gases, Vet­eri­nary Vac­cines man­u­fac­turer (Bi­o­log­i­cal Pro­duc­tion Unit, Na­tional Cen­tre for An­i­mal Health, MoFA) and Men­jong Sorig Phar­ma­ceu­ti­cals (Tra­di­tional medicines).

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