The Kerala Drugs Control department has seized stocks of Novo Nordsik's two costly imported drugs - Norditropin Nordilet, a human growth hormone injection and an emergency multiple bleeding drug Novoseven, from Calicut and Thiruvananthapuram allegedly for selling without proper sales documents and marketing license.
According to sources with the department, a team of officials recently seized vials of Norditropin Nordilet, a human growth hormone injection and Novoseven, a Coagulation Factor VII-a (Recombinant) indicated for the treatment of bleeding episodes in Haemophilia A or B patients, worth Rs.2 lakh from a lodge at Kozhikkode. A subsequent raid conducted by the officials at Thiruvananthapuram resulted in seizure of the same drugs sold without credit invoice by a retail pharmacy shop, worth Rs 1.8 lakh.
The drug control officials informed that a multi-disposable pen or vial of 15mg/1.5 ml Norditropin Nordilet with an MRP of Rs 17,000, usually used for a single injection or treatment course, and 2.4 mg Novoseven pre-syringe powder prices at around Rs. 79,000 per vial, were offered for sale at the lodge with a margin of around Rs.2,000 and Rs. 20,000 per vial respectively by the representative of the distributor. The officials booked an employee from the Bangalore based MedIndia, the authorised all India distributor of these two drugs, for attempting to sell the prescription drug illegally in a lodge.
The authority charged cases against the distributor, under 18(c) and 22(1) (cca) of Drugs and Cosmetics Act, 1945. Under 18(C), the punishment is imprisonment not less than one year to three years and fine not less than Rs.5,000 for selling the drug without license. Under 22(1)(cca) of the Act, the offender is booked with a provision for imprisonment up to one year or fine up to Rs.1,000 or both, and empowers the officials to summon relevant documents of sales.
The officials said the seizure is a first of its kind incident in Kerala. They said the department suspect existence of a parallel illegal drug sales network extensively operating in Kerala, dealing with costly medicines and supported by some physicians in the state.
Meanwhile, when Pharmabiz contacted Novo Nordisk sources, they said the incident at Kozhikkode could be a planned attempt to tarnish the image of the company, hatched by 'some people who tried to get a dealership for the products'. They also ruled out existence of an illegal racket dealing with products of Novo Nordisk.
"These two drugs are not commonly stocked in medical shops as they are very costly and we supply it on emergency requests to hospitals or physicians or medical shops. If I get a call to supply a life saving drug like Novo-7 urgently, it is my duty to ensure the drug reaches the hospital on time to save the life of a patient. We sell such drugs only as per the prescription of doctors. These two drugs are hardly sold in Kerala" reasoned Ashok Rao, sales manager Novo Nordisk.
He said MedIndia is the authorised national distributor for these imported drugs from Novo Nordisk and the company has secured necessary licenses to sell it in the country. While Novo-7 is a relatively new drug which was introduced in India only a year ago, Norditropin is an old drug with at least six to ten popular rival brands available in the market. Sales for both the drug are 'not much' in the country, said Ashok Rao.
He said the company and its distributor have submitted all the relevant documents authorising the company to sell the product in India to the Kerala drug control department, following the development.