Hyderabad: It might be quite perplexing for the common man to understand but for caregivers, it just makes perfect sense. While many, even to this day, struggle to buy a pack of condoms from the pharmacy, regulatory authorities, however, have decided to elevate condoms to higher standards.
From April 1, the Ministry of Health and Family Welfare will start treating a variety of medical devices as drugs. Included in the long list of the medical devices are condoms too, which will now undergo strict quality management systems and design controls.
The inclusion of condoms in the list of drugs might come across as a bit surprising. However, regulatory authorities, including the Health Ministry, consider condoms essential contraceptive devices, which provide vital protection from sexually transmitted diseases (STDs) as well.
They are considered the first line of defence for HIV and hence, they must be produced in a clean environment to minimise microbiological contamination of the product during manufacturing and packaging. Senior health officials point out that condoms contain lubricants and additives, and such products should not have toxic substances, which are likely to produce allergies, a reason why they need to be regulated.
USFDA considers condoms as medical devices
The need to treat condoms as medical devices and introduce quality regulations during their production is already an established practice by the US Food and Drug Administration (USFDA).
The condoms (including imported ones) in the United States are randomly subjected to stringent manufacturing standards. The USFDA has relevant data and guidelines for the correct manufacturing practice for both male latex and female polyurethane condoms, which go a long way in preventing transmission of HIV and STDs.
Some of the other major medical devices that will now be regulated by the Health Ministry include stents, heart valves, tubal rings, surgical dressings, blood pressure monitors, glucometers, digital thermometer, X-ray machines etc.