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 is Schedule C and C1 Drugs?
Schedule C and C1 drugs includes biological and special products. Schedule C and C1 under drug and cosmetic act & rules covers generally serum, hormones, vaccines, toxins, anti toxins and other biological and special products.
For manufacturing for sale and distribution of Schedule C and C(1) drugs, A license on Form number 28 is required which is issued by Drug Department of concerned state government or center government. For retail sale of these drug, a license on Form 21 is required where as for wholesale sale and distribution purpose, license on Form 21-B is required. Below are the list of products that are covered under Schedule C and C(1).
Form number required for application of schedule c and c1 Drugs:
Form Number 19/19A: Applications for the grant or renewal of a licence to sell, stock, exhibit or offer for sale or distribute drugs, other than those included in Schedule X, shall be made in Form 19 or Form 19A, as the case may be
Form Number 27: Application for grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in Part XB and Schedule X
Form Number 27A: Application for grant or renewal of a loan licence to manufacture for sale or for distribution of drugs specified in Schedules C and C(1) excluding those specified in Part XB and Schedule X
Form Number 27B: Application for grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedules C, C(I) and X
Licence for drugs specified in schedule c and c1 are issued in Form:
Form 21 (Rule 61 (2): Licence to sell, stock or exhibit or offer for sale, or distribute by retail drugs specified in Schedules C and C (1) excluding those specified in Schedule X
Form 21A (Rule 61 (2): Licence to sell, stock or exhibit or offer for sale, or distribute by retail drugs specified in Schedule C (1) excluding those specified in Schedule X for dealers who do not engage the services of a registered pharmacist
Form 21B (Rule 61 (2): Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale drugs specified in Schedules C and C (1) excluding those specified in Schedule X
Form 21BB (Rule 62D): Licence to sell by wholesale or to distribute drugs specified in Schedule C and Schedule C (1) to the Drugs and Cosmetics Rules, 1945 from a motor vehicle
Form 21C (Rule 63A): Certificate of renewal of licence to sell, stock or exhibit or offer for sale, or distribute] drugs
Form 21CC (Rule 63B): Certificate of renewal of licence to sell, stock or exhibit or offer for sale by wholesale, or distribute] drugs from a motor vehicle
Form 28 (Rule 76): Licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in Schedule X
Form 28A (Rule 76-A): Loan Licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in Schedule X
Form 28B (Rule 76): Licence to manufacture for sale or for distribution of drugs specified in Schedules C, C(I) and X
Form 28D (Rule 76): Licence to manufacture for sale or for distribution of 2[Large Volume Parenteral/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs] specified in Schedules C and C(I) excluding those specified in Schedule X
Schedule C: Biological and Special Products
- Sera.
- Solution of serum proteins intended for injection.
- Vaccines for parenteral injections.
- Toxins.
- Antigen.
- Antitoxins.
- Neo-arsphenamine and analogous substances used for the specific treatment of infective diseases.
- Insulin.
- Pituitary (Posterior Lobe) Extract.
- Adrenaline and Solutions of Salts of Adrenaline.
- Antibiotics and preparations thereof in a form to be administered parenterally.]
- Any other preparation which is meant for parenteral administration as such or after being made up with a solvent or medium or any other sterile product and which-
- requires to be stored in a refrigerator; or
- does not require to be stored in a refrigerator.
- Sterilized surgical ligature and sterilized surgical suture.
- Bacteriophages.
- Ophthalmic preparations.
- Sterile Disposable Devices for single use only.
Schedule C (1): Other Special Products
- Drugs belonging to the Digitalis group and preparations containing drugs belonging to the Digitals group not in a form to be administered parenterally.
- Ergot and preparations containing Ergot not in a form to be administered parenterally.
- Adrenaline and preparations containing Adrenaline not in a form to be administered parenterally.
- Fish Liver Oil and preparations containing Fish Liver Oil.
- Vitamins and preparations containing any vitamins not in a form to be administered parenterally.
- Liver extract and preparations containing liver extract not in a form to be administered parenterally.
- Hormones and preparations containing Hormones not in a form to be administered parenterally.
- Vaccine not in a form to be administered parenterally.
Q&A:
Question: In which schedule insulin comes under?
Answer: Schedule C
Question: Biological drugs belong to which schedule?
Answer: Schedule C
Question: How to get license for manufacturing of drugs in schedule c and c1?
Answer: Fulfill all criteria for applying license for manufacturing of pharma products as specified by us in our article : How to start a pharmaceutical manufacturing company in India?
You can follow that link and read all requirements.
For Manufacturing license of drugs in schedule c and c1, you need to apply at Form Number 27 and you will get License number in Form 28 to manufacture for sale or for distribution of drugs specified in Schedules C and C (1).
Question: Ensure the schedule for biological and special product
Answer: Schedule C and C1
Question: In which schedule vaccine, sera, insulin is included?
Answer: Schedule C and C1
Question: Which is not an example of schedule “c” drug?
Answers: Paracetamol, Rabeprazole and antibiotics etc are the examples which are not Schedule ‘C’ drug.
Question: Digitalis belongs to which schedule?
Answer: Schedule C1
Question: Vitamin preparations are belong to which schedule?
Answer: Belong to Schedule C1 but not in a form to be administered parenterally.
Question: Ergot and its preparations comes under which schedule?
Answer: Belong to Schedule C1 but not in a form to be administered parenterally.
Hope above information is helpful to you…
For any query or suggestion, mail us at pharmafranchiseehelp@gmail.com
Hi Ajay sir. Greetings of the day. I want to obtain Loan License for Hand Sanitizer, Disinfectant & Floor cleaner manufacturing in Maharashtra. Which schedule and which form will be applied. Please guide me.
1. Monoclonal Antibody comes under which category of schedule?
2. What Form number is required to obtain a license for the manufacture monoclonal antibody Active Biological Ingredients (ABI)?
3. Can we manufacture monoclonal antibody Active Biological Ingredients (ABI) in India at any biological manufacturing facility for USA/EU market without regional (Indian FDA) manufacturing license approval of that site and sale it to export or USA and EU markets?
Sir/ ma’am …, : is all the parenteral formulation are come under the schedule c drugs? Basically I’m plan for Drug inspector ,and in eligibility criteria for drug inspector , candidate should have experience in schedule c drug manufacturing and testing.so can I join any parenteral manufacturing company for experience?
Sir/ mam : is all the parenteral formulation are come under the schedule c drugs? Basically I’m plan for Drug inspector ,and in eligibility criteria for drug inspector , candidate should have experience in schedule c drug manufacturing and testing. so can I join any parenteral manufacturing company for experience?
POTASSIUM CHLORIDE COMES UNDER WHICH SCHEDULE ?
WHAT FORM AND LICENCE REQUIRED FOR MANUFACTURING OF IP GRADE POTASSIUM CHLORIDE.
Mam & sir how to apply for drug inspector job
Is herbal product like septilin and Liv 52 HB Capsule come under scheduled c