United states health regulators FDA warns India’s CADILA HEALTHCARE Ltd for violating manufacturing standards at two production sites in india.
The letter from US Food and drug Administration cites issues at Cadila’s plants in GUJRAT; The Moraiya drug production site and another in Ahmedabad city where it makes drug ingredients.
FDA inspected the MORAIYA Plants in September 2014 but the warning comes more than a year later highlighting a number of problems at the plants.Although CADILA said its work to fix the issues was complete.But it has not received US approvals for drug made at the plant for a year. CADILA also said in a statement that it was committed to resolve all the issues and revamp our quality systems and processes as the top most priority. At AHMEDABAD plant CADILA said none of its products being sold in the United STATES used any raw materials made at the plants.
ONLINE SALE OF MEDICINES ILLEGAL Drug Controller The DRUGS CONTROLLER GENERAL OF INDIA said that “there is no provisions for the sale of online drugs under any Act till date and we will start shutting e-pharmacies for the sake of patients safety. while most e-pharmacies claim to operate under the provisions of the Drugs and cosmetics(D&C)Act.Now the govt.is ready to crack the whip on the burgeoning illegal ecosystem of online medicine sale.
The Drugs and Cosmetics Rules regulate the sale and distribution of drugs in the country and do not distinguish between conventional and over the internet sales. The DCGI G N SINGH also said that” There was no internet when the D& CAct was framed.this means that present eco-system of e-pharmacy is totally illegal and attracts punishments under Indian Penal Code provisions.The DCGI’S office has issued a circular to instruct drug control administrators of the states to take action against those indulging in online sale of drugs in the interest of public health.