Growing a pharma business requires a strategic approach considering the specific context of your company and the pharmaceutical industry as a whole. Here are some general pointers to get you started: Market and Customer: Identify your target customer: Deeply understand the specific needs and challenges of your target audience, whether it's doctors, patients, hospitals, or other healthcare providers. This helps tailor your products, services, and marketing efforts. Focus on unmet needs: Look for gaps in the market where existing solutions are inadequate or unavailable. Addressing unmet needs can give you a competitive edge and drive innovation. Track market trends: Stay updated on regulatory changes, technological advancements, and emerging diseases to adapt your approach and anticipate future opportunities. Products and Services: Invest in R&D: Develop innovative products or differentiate existing ones through unique formulations, delivery methods, or combinations. Remember
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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