Regulator issues alert over sale of falsified versions of 2 drugs

Subject :Science and Technology

Section: Health

In the news:

The Drugs Controller General of India (DCGI) has directed the drugs controllers of all States and Union Territories to keep a strict vigil on the sale and distribution of falsified versions of two drugs, liver medication Defitelio and Takeda’s cancer drug Adcetris (injection), following alerts issued by the World Health Organization (WHO).

WHO Advisory:

Against falsified versions of Adcetris injection 50 mg manufactured by Takeda Pharmaceutical Company Limited, identified in four different countries including India and Turkey.
Against a falsified version of Defitelio (Defibrotide) 80 mg/ml concentrate for solution for infusion, manufactured by Gentium Srl.
Against Abbott’s antacid Digene gel, citing safety concerns, which is manufactured at a Goa facility.

Adcetris:

Adcetris (Brentuximab Vedotin) is a CD30-directed antibody-drug conjugate indicated for the treatment of patients with Hodgkin’s lymphoma after the failure of an autologous stem cell transplant and systemic anaplastic large cell lymphoma.

Laws in India to regulate medicines:

The Drugs & Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs in India.
India is also the world’s leading producer of fake drugs, according to research by the Organisation for Economic Co-operation and Development (OECD) and the European Union’s Intellectual Property Office.
In 2003, Mashelkar Committee noted that although the Drugs and Cosmetics Act 1940 has been in force, the level of enforcement in many States has been unsatisfactory.

Central Drugs Standard Control Organisation (CDSCO):

The CDSCO is India’s national regulatory body for cosmetics, pharmaceuticals and medical devices.
The Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO).
Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and is positioned within the Ministry of Health and Family Welfare.
The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
Divided into zonal offices, each one carries out pre-licensing and post-licensing inspections, post-market surveillance, and drug recalls (where necessary).
Manufacturers who deal with the authority required to name an Authorized Indian Representative (AIR) to represent them in all dealings with the CDSCO in India.
CDSCO plans to open an international office in Beijing, China.