How to Start Pharmaceutical Business

Query: We are a skincare brand that is looking to sell OTC products direct-to-consumer. Could you please help me understand what restrictions there are to this and whether we need a wholesale license to do this? I am unable to find the list of drugs which are classified as OTC as opposed to prescription, and could really use your help! Thank you so much. Response: All products that are manufactured under pharmaceutical products whether it is OTC or prescription, there is a requirement of drug license (wholesale or retail) to sell it. You will require a retail drug license to sell it directly to consumers... There are not specially mentioned anywhere about prescription drugs and OTC drugs. Generally all Schedule H, H1, X are considered prescription drugs as they can't be sold without prescription of registered medical practitioner excluding those intended for topical or external use (except ophthalmic and ear / nose preparations). Check out Prescription Drugs list in India

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 C and C(1) described the list of biological and special products list. Schedule C: Biological and Special Products List of products is as follow: 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 ...

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 B under drug and cosmetic act & rules define the fees charged by central drug laboratory or state drug laboratory for testing and analysis. Fee mentioned here as per Drug and Cosmetic Act & Rule amended till upto 31 st December 2016. There may be change in fee or any other particulars based upon latest government notification. For more detail refer  Drug and Cosmetic Act

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 E(1): Schedule E(I) describes the List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine (Ayurvedic Prescription Drugs List) List of poisonous substances under Ayurvedic System of Medicines: I. Drugs of vegetable origin Ahipena (Except seeds) - Papaver somniferum Linn Arka - Calotropis procera (Ait.) R.Br. ex. Bhallataka - Semecarpus anacardium Linn. F. Bhanga (Except seeds) - Ca...

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 D (Rule 43) is related to import of drugs into India. Schedule D provides information about extent and condition of exemption for a class of drug in case of import. Schedule D(I)(Rule 21D and 24A): Information and undertaking required to be submitted by the manufacturer or his authorized agent with the Application Form for a Registration Certificate. The format shall be properly filled in for each application in Form 40. The deta...

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 H: Prescription Drugs List Schedule H describes the list of prescription drugs. List of Drugs is as follow: 1. Abacavir 2. Abciximab 3. Acamprosate calcium 4. Acebutol hydrochloride 5. Aclarubicin 6. Albendazole 7. Alclometasone dipropionate 8. Actilyse 9. Acyclovir 10. Adenosine 11. Adrenocorticotrophic hormone (acth) 12. Alendronate sodium 13. Alopurinol 14. Alphachymotrypsin 15. Alprazolam 16. Al...

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 H1 Drugs List: Schedule H1 describes the list of prescription drugs requires prevention of misuse. List of schedule H1 drugs are as follow: Alprazolam Balofloxacin Buprenorphine Capreomycin Cefdinir Cefditoren Cefepime Cefetamet Cefixime Cefoperazone Cefotaxime Cefpirome Cefpodoxime Ceftazidime Ceftibuten Ceftizoxime Ceftriaxone Chlorodiazepoxide Clofazimine Codeine Cycloserine Diazepam Diphenoxylate Dorip...

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 G (Rule 97): Schedule G describes the list of drugs: Aminopterin L-Asparaginase Bleomycin Busulphan; its salts Carbutamide Chlorambucil;its salts Chlorothiazide and other derivatives of 1, 2, 4 benzothiadiazine Chlorpropamide; its salts Chlorthalidone and other derivatives of Chlorobenzene compound Cis-Platin Cyclophosphamide; its salts Cytarabine Daunorubicin Di-Isopropyl Eluorophosphate Disodium Stilboestrol Dipho...

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 K (Rule 123): Schedule K describes the class of drugs and their extent and condition of exemption from all provisions of drug and cosmetic act. Schedule K allowed some drugs from falling under drug and cosmetic act, and allow to use, sell without provisions of drug and cosmetic act. For more detail refer  Drug and Cosmetic Act

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 L and Schedule L1: Schedule L (Omitted) Schedule L-1 (Rule 74,78 and 150E): Schedule L describes the good laboratory practices and requirements of premises and equipments. General Requirements Premises Personnel Equipments Chemical and Reagents Good Housekeeping and Safety Maintenance, calibration, and validation of equipments Reference materials Microbiological Cultures Quality System Internal Qual...

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 J (Rule 106): Diseases and ailments (by whatever name described) which a drug may not purport to prevent or cure or make claims to prevent or cure. 1. AIDS 2. Angina Pectoris 3. Appendicitis 4. Arteriosclerosis 5. Baldness 6. Blindness 7. Bronchial Asthma 8. Cancer and Benign tumour 9. Cataract 10. Change in colour of the hair and growth of new hair. 11. Change of foetal sex by drugs. 12. Congenital malfor...

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 M-I: Schedule M-I describes the good manufacturing practices and   requirements of premises, plant and equipment for homoeopathic medicines. 1.        General Requirements §   Location and Surroundings §   Building 2.        Plant and Equipements §   General ·          Rooms ·    ...