Whalesbook
USFDA Inspection ka Funda Kya Hai?
Dekho, USFDA yani America ki food and drug regulatory body ne Zydus ke Ahmedabad, Changodar wale plant mein April 27 se May 5 tak ek quality check (GMP inspection) kiya tha. Is inspection mein 7 alag-alag points par company ko improve karna hoga, jise 'observations' kehte hain. Yeh koi final judgement nahi hai, par yeh batata hai ki quality standards mein kuch kami hai.
Sabse achhi baat yeh hai ki company ne kaha hai ki data integrity mein koi problem nahi mili hai. Matlab, jo data wo FDA ko dete hain, woh sab sahi hai. Yeh ek bahut bada plus point hai.
Toh Ab Aage Kya Hoga?
Par woh jo 7 observations mili hain, unhe Zydus ko jaldi se jaldi theek karna hoga. Agar time pe theek nahi kiya toh naye products ke approval mein deri ho sakti hai aur jo products already market mein hain, unki supply mein bhi gadbad ho sakti hai. Serious cases mein toh import par rok bhi lag sakti hai.
Zydus Ka Response Aur Market Ka View
Zydus ne bola hai ki wo USFDA ke saath milkar sab observations ko quickly resolve karenge. Company ke liye yeh bahut important hai kyunki unke exports kaafi zyada US market par depend karte hain. Pichhle records dekhenge toh pata chalega ki Zydus aise regulatory issues ko kaise handle karta hai. Investors ab yeh dekhna chahenge ki is sab ko theek karne mein kitna kharcha aata hai aur injectable products ki future earnings par iska kya asar padega.