Over time, drug sales have increased, and the prescription management formulary is continually expanding with new medications. The drug regulatory agency schedules the pharmaceuticals according to their therapeutic impact to ensure the end user's safety.
The Pharmaceuticals and Cosmetics Act distinguishes between prescription drugs, narcotic and psychotropic substances, over-the-counter drugs, and medical devices to promote safety in public health.
This scheduling system aids in identifying the types of both new and existing pharmaceuticals for use by lawmakers, law enforcement, and healthcare practitioners.
What are drugs under Schedule H1?
Sensitive antibiotics, habit-forming pharmaceuticals, and medications with serious side effects if used without supervision and a prescription from a licensed medical professional are all listed as Schedule H1 substances.
This Schedule was put into place to strictly regulate the medications it included for the benefit of the general population.
Schedule H1 medications cannot be purchased without a current prescription, as has been the talk for some time. To comprehend this precisely, you must understand the applicable ACT, the Drugs and Cosmetics Act, and its implementing regulations.
According to science, Schedule H1 pharmaceuticals include habit-forming medications such as psychiatric drugs, third- and fourth-generation antibiotics, and anti-tuberculosis medications. The Schedule H1 drug list substances may be purchased and sold only with a licensed physician's prescription.
Schedule H1 Drugs:
Third- and fourth-generation antibiotics, antituberculosis medications, and several habit-forming medications, including psychiatric pharmaceuticals, are all included on the schedule H1 drug list.
Two requirements must be correctly adhered to deliver these medications.
- When a drug is administered by the schedule H1 specification, the name of the patient, the prescriber's name and address, the drug's name, and the quantity supplied should all be noted in a separate register. This registration should be accessible for examination and must be kept confidential for three years.
- The red Rx symbol should be prominently placed on the left top corner of the drug label for all scheduled H1 medications. The following words should also appear on the label in a box with a red border.
Drug Schedule H1 Warning:
- It is unsafe to use this medication unless directed to do so by a doctor.
- Not to be sold at retail without a registered medical practitioner's prescription.
Why did Schedule H1 become available?
After discovering that any number of these medications could be purchased from pharmacies across India without any restrictions, the schedule H1 drugs were primarily assigned to restrict the sale of antibiotics through over-the-counter (OTC) sales.
Antibiotic resistance and psychiatric drug tolerance are on the rise due to irrational prescriptions for antibiotics and other medications by physicians and pharmacists without a registered pharmacist.
1. Many medical professionals and educational institutions have organized meetings to discuss the dangers of antibiotics.
2. These meetings are a way for professionals and educators to learn more about antibiotics and their potential dangers.
The Government of India recognized the significance of this schedule by issuing a gazette notification, GSR 588 (E), dated August 30, 2013, respecting category H1 Drugs.
Drugs on the Schedule H1 list
- Alprazolam
- Balofloxacin
- Buprenorphine
- Capreomycin
- Cefdinir
- Cefditoren
- Cefepime
- Cefetamet
- Cefixime
- Cefoperazone
- Cefotaxime
- Cefpirome
- Cefpodoxime
- Ceftazidime
- Ceftibuten
- Ceftizoxime
- Ceftriaxone
- Chlordiazepoxide
- Clofazimine
- Codeine
- Cycloserine
- Diazepam
- Diphenoxylate
- Doripenem
- Ertapenem
- HCl ethambutol
- Ethionamide
- Faropenem
- Gemifloxacin
- Imipenem
- Isoniazid
- Levofloxacin
- Meropenem
- Midazolam
- Moxifloxacin
- Nitrazepam
- Pentazocine
- Prulifloxacin
- Pyrazinamide
- Rifabutin
- Rifampicin
- Para-aminosalicylate sodium
- Sparfloxacin
- Thiacetazone
- Tramadol
- Zolpidem
However, there is no restriction on using the medications as topicals or for external use, such as in ophthalmic, ear, or nose preparations, on the schedule H1 drug list.
A gazette notice by itself won't assist, as is well known. In addition, various actions must be taken by the relevant authorities at all levels.
These are what they are:
- Monitoring OTC sales
- Analyzing antibiotic sensitivity and resistance trends
- Implementing sensible antibacterial and psychotropic measures in a medical facility
- Raising knowledge of the prudent use of antibiotics in teaching medical institutions as well as at other levels of medical settings
- Frequently inspecting pharmacies
Differences between drugs on Schedules H and H1
Pharmaceuticals formerly classified as schedule H, such as antibiotics, anti-TB medications, and habit-forming substances, have been shifted to a new subcategory known as schedule H1. Otherwise, there are no significant differences between Schedule H and Schedule H1 drugs.
1. To buy Schedule H and H1 drugs, you need to get a prescription from a registered medical practitioner.
2. The regulations for these drugs are quite strict, which is why you need a prescription to buy them.
For schedule H1 medications, where there is no requirement for retaining records for drugs that fall under schedule H, a suitable form of every sale, purchase, prescription copy, patient detail, doctor detail, etc.
Conclusion
SwilERP classifying medications as scheduled drugs, it is possible to eradicate illegal drug trafficking activities while preserving patient safety and health. In the end, registered pharmacists must be fully aware of their obligation to manage medications dispensed through their pharmacy by the applicable drug regulation law.
