List OF Schedule C and C1 Drugs And Formulations

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The Drugs and Cosmetics Rules, 1945 contains provisions for classification of drugs under the given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.
These Schedules Contains various biological products and their regulation.
Here is the list of Schedule C and C1 Drugs in India

[Rule 23, 61 and 76 and Part X]

1. Sera.
2. Solution of serum proteins intended for injection.
3. Vaccines for parenteral injections
4. Toxins.
5. Antigen.
6. Antitoxins.
7. Neo-arsphenamine and analogous substances used for the specific treatment of infective diseases.
8. Insulin.
9. Pituitary (Posterior Lobe) Extract.
10. Adrenaline and Solutions of Salts of Adrenaline.
11. Antibiotics and preparations thereof in a form to be administered parenterally.
12. 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—
1. requires to be stored in a refrigerator; or
2. does not require to be stored in a refrigerator.
13. Sterilized surgical ligature and sterilized surgical suture.
14. Bacteriophages.
15. Ophthalmic preparations.
16. Sterile Disposable Devices for single use only.

[Rule 23, 61 and 76]

1. Drugs belonging to the Digitalis group and preparations containing drugs belonging to the Digitalis group not in a form to be administered parenterally.
2. Ergot and preparations containing Ergot not in a form to be administered parenterally.
3. Adrenaline and preparations containing Adrenaline not in a form to be administered parenterally.
4. Fish Liver Oil and preparations containing Fish Liver Oil.
5. Vitamins and preparations containing any vitamins not in a form to be administered parenterally.
6. Liver extract and preparations containing liver extract not in a form to be administered parenterally.
7. Hormones and preparations containing hormones not in a form to be administered parenterally.
8. Vaccine not in a form to be administered parenterally.
9. Antibiotics and preparations thereof not in a form to be administered parenterally.
10. In-vitro Blood Grouping Sera.
11. In-vitro Diagnostic Devices for HIV, HbsAg and HCV.

We will compile all rules and regulations related to schedule C and C1 drugs in separate post.

59 thoughts on “List OF Schedule C and C1 Drugs And Formulations”

    1. All categories of antibiotics which are prepared to be administered paternally comes under schedule C. And other antibiotics formulations like capsules and tablets comes under Schedule C1.

  1. i need 18 months experience in licensed company having to manufacture of schedule c and c 1 drug.
    For drug inspector.

    i completed B.pharm &reg. in state pharmacy council.

    which post i need to join in the companies, ( As trainee, pharmacist, etc..)
    i’m confusing plz give me some tips.

    whether completion of training duration 2 years, whether they give as experince certificate as worked in mfg in sch C and C1.
    Is it valid work exp. in DRUG INSPECTOR. please reply.

    1. just find a regular job in any pharma company big or small, In manufacturing sector or QA/QC.
      During job You should be associated with the production process of any schedule c/c1 drug in any capacity,
      should be doing analysis and tests on schedule c/c1 drugs.
      Every company provides experience certificate, just keep your terms fine with them.
      Some states do not require experience. read this post
      Eligibility And Qualification For Drug Inspector In India

  2. sir
    I have completed my b.pharm from maharashtra SUK university, kohlapur
    having no experience and didn’t having knowledge about other states regional languages can I apply for other state exam .??

    1. Sorry we missed your comment as you asked on unrelated post. you can apply in other states but working knowledge of states language is required. See the states vacancies for clarification. But if you at-least know hindi apart from marathi you can apply in many northern states.

  3. Dear sir,
    whether ( CLOVISTA-625) Amoxycillin and Potassium Clavulanate combination to treat RTI, UTI and gynaecological infections. tablets are coming under schedule C &C1 ?.

    i’m working in manufacturing CLOVISTA-625 as a trainee (b.pharm) in hll life care plant, belagavi.

    please reply me,
    18 moths expr in mfg of CLOVISTA-625 , as trainee is valid for karnataka drug inspector .

  4. I have done b.pharm.
    And i have 2 yrs experience in testing of surgical sterile sutures and disposables devices..
    So will this experience count for DI..
    only need to experience in parenterals biopharmceuticals

    1. Licence on Form 21 is issued for retail sale of Allopathic drugs specified in Sch C & C(1).(Form-19)

      Licence on Form 21-B is issued for wholesale of Allopathic drugs specified in Sch C & C(1). (Form-19)

      Licence on form 21-A is issued for retail sale of restricted Allopathic drugs specified in Schedule C (I). (Form-19A)

      Licence on Form 20-F is issued for retail sale of drugs specified in Sch. ‘X’. (Form-19-C).

      The above licenses are used if you want to resale drugs of other brands.

      If you want to sell your own brand then first register your company. Get GST Number, Get trademarks. Get license valid for wholesale on 21 B ,contact a company with loan license to manufacture for your brand. Then you can market your product and sell to retail.

  5. Sir,
    I have B.Pharma & 2 Yrs experience in Multivitamin syrup manufacturing company as manufacturing trainee chemist. So will this experience count DI…..Or not.

  6. I am.pharm passout and working in a analytical laboratory for past 2 years,will this experience be considered under eligibility critera for drug inspector or have to work specifically in a pharmaceutical company.??

  7. I’m working in a DMPK department (Drug metabolism and Pharmacokinetics), where we analyze many substances both in vitro and in vivo. Will this make me eligible to apply for DI?

    1. testing should be related to the quality of the manufactured c and c1 drug on various parameters. If you test the quality and authenticity of the drug you can mention in experience certificate and apply.

      1. Actually it’s the pre-clinical studies we do. So i think it won’t be considered for DI. Any commnet on this from your side?

    2. c and c1 manfacturing certificate from any company. But testing work experience only from the ‘approved laboratory for this purpose’ is accepted. So preclinical studies do not make you eligible.
      But good thing is, in 2018 notificaton upsc did not ask for mandatory experience. Also in many states you can without experience.

  8. Sir,
    I have completed my M-pharm, in pharmaceutics, and presently working in Drug regulatory affairs from last 14 months, so am i eligible to apply for Drug inspector in Maharashtra.
    Please reply.
    Thank You.

  9. sir, I have completed my m pharm and I have regulatory affairs experience of 17 months with my first company which manufactures antibiotics and parenteral +ophthalmic products. Further I have 1 year experience in QA-Regulatory supervision (which is also work of regulation in conjunction with QA) in another company which have microbiology based products of schedule C i.e. serum & schedule C1 i.e. antibiotic discs- not used for human administration, will it be eligible for drug inspector post of central government (UPSC) and state government??? Please guide me sir or else I will have to switch QC profile in other company?

    1. if you were involved only in regulatory documentation work then it will not be sufficient when experience is essential. You should be involved in testing directly.
      But most state governments do not ask for 18 months experience. Also in 2018 notification upsc did not ask for mandatory experience. so you can apply without experience.

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