Schedule R and R1


Schedule R (Rule 125): 

Schedule R Describes the Standards for condoms made of rubber latex intended for single use and other mechanical contraceptives

I. Condoms
  1. Description
  2. Materials
  3. Procedure for sampling during production
  4. Procedure for sampling and testing of finished products by a manufacturer
  5. Procedure for sampling and testing of condoms by a purchaser
  6. Sampling plan for a Drugs Inspector
  7. Sampled condoms drawn under sub-paragraph
  8. Dimension
  9. Bursting Volume and Pressure Test
  10. Water Leakage Test
  11. Quantity of Lubricant
  12. Colour Fastness
  13. Labelling, packing and storage
  14. Integrity of individual package seals

II. Other Mechanical Contraceptive

Standards for other mechanical contraceptive - Standards for “Copper T” and “Tubal Ring” shall be as laid down in Annexure VI

After standards, annexure details are provided. Annexure are as follow:

Annexure I
Annexure II
Annexure III
Annexure IV
Annexure V
Annexure VI

Schedule R1 (Rule 109A, 109, 109C and 125A):

The medical devices shall conform to the Indian Standards laid down from time to time by the Bureau of Indian Standards. If there are no Bureau of Indian Standards then it shall conform to the International Standards, like International Organisation for Standardisation, or other International Pharmacopeia Standards and such other standards as may be specified for this purpose. In case national or international standards are not available, the device shall conform to the manufacturer‘s validated standards

For more detail refer Drug and Cosmetic Act

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