Query: I am a veterinarian by profession. Have been going through your website from past 1 year and have planned now to give a start to my own pharma company. Please let me know what will be the first step I need to take. Answer: First Step you need to prepare yourself for Pharmaceutical Company: Preparation means Choose marketing type, Choose molecules want to launch, Location where you want to launch product, Choose Company, Products Name, Budget available... Choose marketing type: As number of marketing and selling types present in pharmaceutical market. i.e. Branded Marketing , Generic Marketing , OTC Marketing, Franchise Marketing etc. You need to select any one from above. Choose Molecule: Once you have selected which marketing type is best suitable for you then you need to select at which segment and molecules you want to work. Check out: How to choose products/service for business? Location: You can't launch your pharmaceutical company all over India or at broad area.
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 describes the list of prescription drugs requires prevention of misuse. List of schedule H1 drugs are as follow:
Note:- Preparations containing the above drug substances and their salts excluding those intended for topical or extrenal use (except ophthalmic and ear or nose preparations) containing above substances are also covered by this Schedule
Labeling Requirements:
A) If it contains a drug substance specified in Schedule H1, be labeled with symbol Rx, which shall be in red and conspicuously displayed on the left top corner of the label and shall also be labeled with the following words in legible black coloured font size in completely red rectangular box:
SCHEDULE H1 PRESCRIPTION DRUG – CAUTION − It is dangerous to take this preparation except in accordance with the medical advice. − Not to be sold by retail without the prescription of a Registered Medical Practitioner.
B) if it contains a drug substance specified in Schedule H1 and comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) be labeled with symbol NRx, which shall be in red and conspicuously displayed on the left top corner of the label and shall also be labeled with the following words in legible black coloured font size in completely red rectangular box:
SCHEDULE H1 PRESCRIPTION DRUG – CAUTION − It is dangerous to take this preparation except in accordance with the medical advice. − Not to be sold by retail without the prescription of a Registered Medical Practitioner.
For more detail refer Drug and Cosmetic Act
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
- Doripenam
- Ertapenem
- Ethambutol Hydrochloride
- Ethionamide
- Feropenam
- Gemifloxacin
- Imipenem
- Isoniazide
- Levofloxacin
- Meropenem
- Midazolam
- Moxifloxacin
- Nitrazepam
- Pentazocine
- Prulifloxacin
- Pyrazinamide
- Rifabutin
- Rifampicin
- Sodium Para-aminosalicylate
- Sparfloxacin
- Thiacetazone
- Tramadol
- Zolpidem
- Oxytocin
Note:- Preparations containing the above drug substances and their salts excluding those intended for topical or extrenal use (except ophthalmic and ear or nose preparations) containing above substances are also covered by this Schedule
Labeling Requirements:
A) If it contains a drug substance specified in Schedule H1, be labeled with symbol Rx, which shall be in red and conspicuously displayed on the left top corner of the label and shall also be labeled with the following words in legible black coloured font size in completely red rectangular box:
SCHEDULE H1 PRESCRIPTION DRUG – CAUTION − It is dangerous to take this preparation except in accordance with the medical advice. − Not to be sold by retail without the prescription of a Registered Medical Practitioner.
B) if it contains a drug substance specified in Schedule H1 and comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) be labeled with symbol NRx, which shall be in red and conspicuously displayed on the left top corner of the label and shall also be labeled with the following words in legible black coloured font size in completely red rectangular box:
SCHEDULE H1 PRESCRIPTION DRUG – CAUTION − It is dangerous to take this preparation except in accordance with the medical advice. − Not to be sold by retail without the prescription of a Registered Medical Practitioner.
For more detail refer Drug and Cosmetic Act
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