Growing a pharma business requires a strategic approach considering the specific context of your company and the pharmaceutical industry as a whole. Here are some general pointers to get you started: Market and Customer: Identify your target customer: Deeply understand the specific needs and challenges of your target audience, whether it's doctors, patients, hospitals, or other healthcare providers. This helps tailor your products, services, and marketing efforts. Focus on unmet needs: Look for gaps in the market where existing solutions are inadequate or unavailable. Addressing unmet needs can give you a competitive edge and drive innovation. Track market trends: Stay updated on regulatory changes, technological advancements, and emerging diseases to adapt your approach and anticipate future opportunities. Products and Services: Invest in R&D: Develop innovative products or differentiate existing ones through unique formulations, delivery methods, or combinations. Remember ...
Schedules: Schedule A, Schedule B, Schedule C, Schedule D, Schedule E1, Schedule F, Schedule G, Schedule H, Schedule H1, Schedule I, Schedule J, Schedule K, Schedule L1, Schedule M, Schedule M1, Schedule M2, Schedule M3, Schedule N, Schedule O, Schedule P, Schedule Q, Schedule R, Schedule S, Schedule T, Schedule U, Schedule V, Schedule W, Schedule X, Schedule Y
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
- Description
- Materials
- Procedure for sampling during production
- Procedure for sampling and testing of finished products by a manufacturer
- Procedure for sampling and testing of condoms by a purchaser
- Sampling plan for a Drugs Inspector
- Sampled condoms drawn under sub-paragraph
- Dimension
- Bursting Volume and Pressure Test
- Water Leakage Test
- Quantity of Lubricant
- Colour Fastness
- Labelling, packing and storage
- 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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