🔹 Condom – As Licensed (as per Drugs & Cosmetics Rules, 1945)
📄 Description:
Condoms are barrier contraceptive devices made from latex, polyurethane, or polyisoprene. They are designed to cover the penis during sexual intercourse, preventing pregnancy and protecting against sexually transmitted infections (STIs) including HIV/AIDS.
In India, condoms are classified under medical devices (Class C) and regulated under the Drugs & Cosmetics Rules, 1945, and Medical Devices Rules, 2017, requiring licensing for manufacture, sale, and distribution.
💊 Prescription / Use:
- Indications:
- Prevention of pregnancy
- Protection against STIs/HIV
- Can be used for emergency contraception along with other methods
- Dosage/Form:
- Single-use male condom (external use)
- Female condoms are also available but less commonly used
- Route: External application over the penis (male) or insertion into the vagina (female)
- No prescription required – available over-the-counter (OTC)
🔬 Nature:
- Barrier contraceptive
- Non-hormonal
- Made from:
- Natural rubber latex (most common)
- Synthetic materials like polyurethane (for latex-allergic users)
- Often lubricated (some also contain spermicides)
🌟 Advantages:
- Prevents pregnancy (85–98% effective)
- Protects against STIs including HIV
- Easily accessible and affordable
- No systemic side effects
- No prescription required
- Enhances shared responsibility between partners
- Available in various sizes, textures, and flavors
📦 Common Packaging:
- Individually sealed foil packs
- Boxed in packs of 3, 10, 12, or bulk packs
- Labeled with:
- Manufacturing license number
- ISI mark (IS 13437) for quality
- Batch number, expiry date, and storage instructions
- May include user instructions or educational inserts
🧊 Storage:
- Store in a cool, dry place, away from:
- Heat
- Sharp objects
- Direct sunlight
- Avoid using expired or damaged condoms
⚠️ Precautions:
- Use a new condom every time you have sex
- Do not reuse
- Use only water-based lubricants with latex condoms (oil-based products can weaken latex)
- Check expiry date before use
- Do not open with teeth or scissors
- Avoid using two condoms at once (friction can cause tearing)
👩⚕️ Patient Advice:
- Correct and consistent use is key for effectiveness
- Can be used with other contraception (e.g., pills or IUDs) for dual protection
- In case of slippage or breakage:
- Use emergency contraception within 72 hours
- Consider STI screening
- Condoms should be disposed of by wrapping in tissue and throwing in the bin – do not flush
- If allergic to latex, use non-latex condoms