Category: Rules and Regulations

License required to sell Natural Medical Remedies

Query: I looking forward for guidance whether a natural mineral used as medical remedy without any process except crushing and screening to size and packing require any registration or licence to sell the same in the market. Response: If you are selling any thing claiming medicinal use or medicinal property, you have to take license. […]

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Is it mandatory to take FSSAI registration for Veterinary Supplements?

Query:   For starting marketing company with veterinary supplement e.g. Liquid calcium Supplement, is it necessary for FSSAI registration as it is not containing any API? And also as my income would be less than 2 Lakhs, is it mandatory to register for GST at the time of starting a marketing..  Response: If you are […]

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Who is responsible for the quality issue of the drug products? manufacturer or supplier/distributor.

Query:   We are planning to enter the pharmaceutical business withing a span of one month and intend to begin as a franchisee in the state of Odisha.However, I have certain doubts as appended below. Who is responsible for the quality issue of the drug products? manufacturer or supplier/distributor. What are the documents/certificates a franchisee […]

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Schedule F, F(1), F(2), F(3), FF

Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Schedule F:  Part I to Part XII-A– Omitted   Part XII B:    Part XII-B describes the requirements for the functioning and operation of a Blood Bank and/or for preparation of Blood components. I. Blood Banks/Blood Components   A. General B. Accommodation for a Blood Bank C. Personnel D. Maintenance E. Equipment F. Supplies […]

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Schedule Y: requirements and guidelines for permission

Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Schedule Y:   Schedule Y describes requirements and guidelines for permission to import and/or manufacture of new drugs for sale or to undertake clinical trials.  

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Schedule X Drugs

Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z What are Schedule X drugs? Schedule X describes the habit forming and narcotics drugs list under drug and cosmetic act & rules. Schedule X drugs mean drugs that aren’t considered safe for patients if taken without supervision of registered medical practioner and additionally these drugs can cause addiction toward these drugs if consumed for […]

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Schedule W- Omitted

Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Schedule W omitted

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Schedule V: Standards for patent and proprietary medicines

Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Schedule V:   Schedule V describes the standards for patent or proprietary medicines Patent or proprietary medicines containing vitamins for prophylactic, therapeutic or paediatric use shall contain the vitamins in quantities not less than and not more than those specified in single or in two divided daily doses.

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Schedule T:Good manufacturing Practice for Ayurvedic, Sidha and Unani Medicines

Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z SCHEDULE T (See rule 157) Schedule T is defined as the schedule of drugs and cosmetic act & rules which represents the good manufacturing practice of asu (ayurvedic, siddha and unani) medicines along with area required for premises, specification required, qualification required, recommended machinery and equipment etc. GOOD MANUFACTURING PRACTICES FOR AYURVEDIC, SIDDHA AND […]

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Schedule S:Standards for Cosmetics

Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Schedule S:   Schedule S describes standards for cosmetics in finished form.− The following cosmetics in finished form shall conform to the Indian Standards specifications laid down from time to time by the Bureau of Indian Standards (BIS) Skin Powders. Skin Powder for infants. Tooth Powder. Toothpaste. Skin Creams. Hair Oils. Shampoo, Soap-based. Shampoo, […]

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