The Drug Control Administration (DCA) of Tamil Nadu is investigating into the seizure of two emergency contraceptive products stocks valued at Rs 55 lakh from Insense Care, a division of the Banglore based Intra Labs India Pvt. Ltd., according to sources.
The DCA has sent a memo to the company and will seek legal opinion on filing a case against marketing of misbranded product with false information in advertisements through local news media, according to the officials. They said that the distributors and the company would be booked for violating the Drug and Magic Remedies (Objectional Advertisement) Acts by selling the product with false information in advertisements.
The product, comprising a composition of Levonorgestrel 0.75 mg, was marketed as an OTC product with advertisements, whereas the drug control authority points out that the particular strength has not been exempted from prescribed drugs under Schedule K. While the central government has announced a plan in September 2005 to endorse the ECP products as OTC under family planning project, the drug control officials informed that the decision is not yet notified and can be only considered when the authority issues a Government Order.
"As per the analytical reports the subject drug is also found to be misbranded. The company claimed IP rights on the product while it is not under IP regime. We are conducting further investigation on the issue and have also sent memos to the concerned parties giving a time of 15 days to respond," N Selvaraju, Drugs Controller (in-charge) told Pharmabiz, when contacted. He added that the administration has seized more than 95 percent of the stock by capturing 1.5 lakh tablets in the state with the two raids within a period of one month after the stocks entered Tamil Nadu.
The sources also informed that the authority is conducting probe on another ECP, from a pharma major, comprising the same strength of combination after seizing the product from the city last month. Though officials refused to comment more, they informed that the investigation on the drug is under progress, and the report will be ready soon.
Responding to the issue, the sources from Insense care informed that the particular formulation, manufactured under a Puthuchery (Pondicherry) based company, is not subject to IP while the combination Levonorgestrel 0.75 mg is under the IP regime. The company has claimed IP in the outer carton, not on the script or on the label of the product, which has been launched about two months ago. They also maintained that claiming IP on the outer carton of a product would not fall under the definition of misbranded products, as the term deals with more serious issues including the failure of the product in usage.
"When the government itself takes step to widen the distribution of the ECPs, by awarding OTC status, we don't know why a controversy has occurred on our product. We have explained the usage of the product in the advertisement so as the laymen in the country can know what an ECP means. We wonder how the advertisement and the product is booked under DMR when the product abides all the regulations," the spokesperson of the company told Pharmabiz. The person also informed that the company is seeking legal opinion on the issue.
The DC department seized the two ECP products from the godowns in the city, after getting a complaint from some of the social organisations and women activists referred by the Commissioner of Police, Chennai city. The activists demanded action against companies under IPC section 274, 275, 76 and various relevant acts, as the distribution of ECPs through abusive advertisement will have a negative effect in the morality of the society. The organizations are planning to strengthen the movement against distribution of ECPs, from five major companies including Cipla, Win medicare, German Remedies and Insense Care in the coming months, according to sources.