In a major state-wide crackdown on wholesalers and retailers across Kerala, the officials of the State Drug Control Department have seized huge quantities of a prohibited fixed dose combination (FDC) drug, Septidase D, manufactured by MMC Healthcare, Solan and marketed by Moly’s Pharma Ernakulam.

Sources from the drugs control department said Government of India had banned the manufacture and sale of this pain killer way back in 1989.

According to sources, despite prohibition, the company has been marketing the drug in Kerala for the last 22 years. The department has registered 147 cases against the C&F agent, wholesalers and retailers, and the number is likely to increase to 400 within two days, a senior officer in the department told Pharmabiz.

The department has initiated action against violation of Rule 26 A of the Drugs and Cosmetics Rules 1945. The seized items are being produced before the respective courts by the offices.

Sources from the Industry said the company has approached the court with their argument following the departmental action.

When contacted, a drug control official in Thrissur district, who has taken four cases against wholesalers, said combination of analgesic and vitamin was banned in India in 1989. Septidase D is a combination of Serratio peptidase, an anti-inflammatory enzyme, diclofenac potassium, analgesic and cobalt, the vitamin element. This combination is not allowed to sell in the Indian market. So the department has registered cases against sale of prohibited drugs, under Rule 26 A, and sale of misbranded drug under Section 17 of the D&C Act.

While interacting with an inspector in Alappuzha, he said the strip of Septidase D contains not the complete details about the contents. The label does not give an idea about what is the Indian Pharmacopoeia standard followed for the manufacture of the drugs.

In response to the regulators’ action, the Chairman of the Retail Chemists Forum in Kerala, C Sanalkumar said the retailers have not been given any information about the prohibition of this drug, and it is the duty of the regulatory officials to inform the wholesalers and retailers about the ban.