List of Schedule H1 Drugs. Difference between Schedule H and Schedule H1

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Topic Covered Under Article:

• What are the Schedule H1 drugs
• Schedule H1 and its implementation in India
• List of Schedule H1 drugs
• Conditions and Time period for which record maintenance require
• Warning
• Difference between Schedule H and H1
• Need of Schedule H1
• Indian Pharmaceutical Market V/s Schedule H1
• Brand names examples of Schedule H1 Drugs

Related: List of Schedule H drugs

What are the Schedule H1 Drugs?

Schedule H1 is a subcategory of Schedule H of the Drugs and Cosmetics Rules, 1945, which regulates the sale and distribution of prescription drugs in India. The aim of Schedule H1 is to curb the indiscriminate use of antibiotics and other prescription drugs that can have serious health consequences if not used judiciously.

These drugs are prescription-only medicines and are subject to stricter regulations compared to other prescription medicines.

Schedule H1 Drugs include antibiotics, anti-tuberculosis drugs, anti-retroviral drugs, and certain other drugs that have a high potential for misuse and can cause serious adverse effects if not used under medical supervision.

Schedule H1 and its implementation in India

The notification for Schedule H1 Drugs was issued on August 30, 2013, by the Ministry of Health and Family Welfare, Government of India. The amendment to the Drugs and Cosmetics Rules of 1945 came into effect on March 1, 2014.

Schedule H1 under the Drugs and Cosmetics Rules, 1945 was introduced vide G.S.R 588(E) dated 30.08.2013 containing carbapenem class and III & IV generation of antibiotics along with certain habit forming and Anti-TB drugs for stricter control over these drugs.

List of Schedule H1 Drugs:

1. Alprazolam
2. Balofloxacin
3. Buprenorphine
4. Capreomycin
5. Cefdinir
6. Cefditoren
7. Cefepime
8. Cefetamet
9. Cefixime
10. Cefoperazone
11. Cefotaxime
12. Cefpirome
13. Cefpodoxime
14. Ceftazidime
15. Ceftibuten
16. Ceftizoxime
17. Ceftriaxone
18. Chlorodiazepoxide
19. Clofazimine Sodium
20. Codeine
21. Cycloserine
22. Diazepam
23. Diphenoxylate
24. Doripenam
25. Ertapenem
26. Ethambutol Hydrochloride
27. Ethionamide
28. Feropenam
29. Gemifloxacin
30. Imipenem
31. Isoniazide
32. Levofloxacin
33. Meropenem
34. Midazolam
35. Moxifloxacin
36. Nitrazepam
37. Sodium Para-aminosalicylate
38. Pentazocine
39. Prulifloxacin
40. Pyrazinamide
41. Rifabutin
42. Rifampicin
43. Sparfloxacin
44. Thiacetazone
45. Tramadol
46. Zolpidem
47. Oxytocin

Note:- Preparations containing the above drug substances and their salts excluding those intended for topical or external use (except ophthalmic and ear or nose preparations) containing above substances are also covered by this Schedule

Conditions:

• The Supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such record shall be maintained for three years and be open for inspection.
• If it contains a drug substance specified in Schedule H1, the drug formulation shall be labelled with the symbol Rx which shall be in Red and conspicuously displayed on the left top corner of the label and shall also be labelled with the following word in a box with red background as mentioned below in warning section.

“SCHEDULE H1 DRUG – WARNING:

-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.”

How to Maintain Schedule H1 Drug Register?

Maintaining a schedule H1 drug register is important to ensure the safe and responsible use of these controlled substances. Here are some tips on how to maintain such a register:

• Keep a separate register for Schedule H1 drugs: Create a separate register specifically for Schedule H1 drugs and ensure that it is easily identifiable and accessible to authorized personnel only.
• Record all relevant information: The supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection
• Supply against Prescription: The supply of any drug on a prescription of a Registered Medical Practitioner shall be recorded at the time of supply in a prescription register specially maintained for the purpose and the serial number of the entry in the register shall be entered on the prescription.
  The following particulars shall be entered in the register:
  (a) serial number of the entry
  (b) the date of supply
  (c) the name and address of the prescriber
  (d) the name and address of the patient, or the name and address of the owner of the animal if the drug supplied is for veterinary use
  (e) the name of the drug or preparation and the quantity or in the case of a medicine made up by the licensee, the ingredients and quantities thereof
  (f) the name of the manufacturer of the drug, its batch number and the date of expiry of potency, if any,
  (g) the signature of the registered Pharmacist by or under whose supervision the medicine was made up or supplied
• Follow proper documentation practices: Ensure that all entries in the register are clear, accurate, and legible. Make sure that any corrections or amendments are properly documented and authorized.
• Conduct regular audits: Regularly audit the register to ensure that all entries are up-to-date and accurate. Conduct spot checks to verify that the physical inventory matches the entries in the register.
• Maintain confidentiality: Ensure that the register is kept confidential and only accessible to authorized personnel. Do not share information about Schedule H1 drugs with unauthorized individuals.
• Ensure proper storage: Store Schedule H1 drugs in a secure and locked area to prevent unauthorized access. Make sure that the storage area meets the requirements outlined in the relevant regulations.
• Stay up-to-date with regulations: Stay informed about any changes to the regulations governing Schedule H1 drugs and ensure that the register is updated accordingly.

By following these tips, you can maintain an accurate and secure Schedule H1 drug register

Difference between Schedule H and Schedule H1:

There is not any major difference between schedule H and schedule H1 drugs but antibiotics, anti-TB drugs and habit forming that were fall under schedule H category was moved to a new sub category that is known as Schedule H1. Schedule H and H1, both categories shall be sold under prescription of a Registered Medical Practitioner only but norm regarding drug fall under Schedule H1 are strict. A proper record of every sale, purchase, prescription copy, patient detail, doctor details under which prescription drugs are sold out etc. shall be maintained for at least three years for schedule H1 drugs where there is no requirement for maintaining record for drug which fall under schedule H drugs. 

Why there is need of Schedule H1?

In recent time, number of cases of antibiotic resistance diseases are increasing. One of the main cause of antibiotic resistance is easy availability and self medication. There was urgent requirement of implementation of any strict laws that Schedule H was not available to implement.

In Indian medicine market whether it will be possible to implement Schedule H1 policy:

Where infrastructure at ground level is of third class. Even in some area there is a lot of Medical Store running without a License or registered pharmacist. One another major problem in Indian Pharmaceutical supply system is that there is a much more chance of drugs without any invoice from its sources i.e. manufactures. In some states where there is tendency and demand of drugs without proper billing. The main reason of this practice is difficulty of getting a particular drug license for retail shop and different tax role at different states. Our drug department also plays a major role in promoting this practices. Corruption is key of this bad practice of pharmaceutical sector. RMP in India have a strong hold particularly in rural area and in areas where there is no medical facilities. For cheap and easy medicine they are beneficial but our country does not have sufficient amount of doctors to feed the requirement of increasing population. So these so called RMP’s is now necessity of some areas in India. These are the person even does not  know the definition of antibiotics and recommend stronger to stronger antibiotic for minor illnesses.  

Adulterated and inferior quality medicines come in market due to not having proper drug distribution system. Secondly we haven’t any system which can distinguish between generic and branded products. On other hand our Drug control system having such drawbacks that anyone can easily escape from it. Political power and Mafia interference also effect the system. In recent years Indian Drug department making a policies to make it at international level but we think there is lot of improvement is required at zero level to make policies effective.Without these we can’t establish a USA type drug delivery system in India. Medicine should be considered life saving not just like a Karyana Store where any one can demand and get.

Until we improve government system , we can not make a healthier and safer India.

Query:

Is it necessary to take cheque from chemist for payment against schedule H1 drugs or we can take cash also, as some of chemist neither wants to fix stamp on bill nor give payment by cheque.

Response:

Payment collection should be in proper manner. Either Cheque or Cash payment receipt. You have to show proper billing and record of all schedule H1 drugs. You have to make sure that in any case chemist don’t refuse to present your bill in front of drug officer. Chemist who don’t want to fix stamp or give payment by cheque don’t want to manage stock of schedule H1 drugs. You have to careful in this matter. In future Schedule H1 is going to be implemented very strictly.

Q&A:

Question: Is alprazolam a Schedule h1 drug?
Answer: Yes, alprazolam is come under Schedule H1.

Question: How many drugs are in a schedule h1?
Answer: Schedule H1 has more than 47 drugs.

Examples of brand names for Schedule H1 Drugs:

• Alprazolam: Alprax, Anxit, Restyl
• Balofloxacin: Balox, Baflox
• Buprenorphine: Buprigesic, Buprenex
• Capreomycin: Capastat
• Cefdinir: Adcef, Cefdiel, Omnicef
• Cefditoren: Spectracef
• Cefepime: Maxicef, Maxipime
• Cefetamet: Altamet, Recocef, Ultipime O
• Cefixime: Cefolac, Fiximark, Suprax
• Cefoperazone: Cefobid, Cefomycin
• Cefotaxime: Cefotax, Claforan
• Cefpirome: Cefrome
• Cefpodoxime: Cepodem, Cefpodoxime Proxetil
• Ceftazidime: Fortum, Ceftazidime Pentahydrate
• Ceftibuten: Cedax, Ceftibuten Dihydrate
• Ceftizoxime: Cefizox, Ceftizoxime Sodium
• Ceftriaxone: Rocephin, Ceftriaxone Sodium
• Chlorodiazepoxide: Librium
• Clofazimine Sodium: Lamprene, Clofazimine
• Codeine: Codistar, Codylex, Corex
• Cycloserine: Seromycin, Cycloserine
• Diazepam: Valium, Calmpose, Anxol
• Diphenoxylate: Lomotil, Diphenoxylate Hydrochloride
• Doripenam: Doribax, Doripenam Sodium
• Ertapenem: Invanz, Ertapenem Sodium
• Ethambutol Hydrochloride: Myambutol, Ethambutol
• Ethionamide: Trecator, Ethionamide
• Feropenam: Merrem, Feropenem Sodium
• Gemifloxacin: Factive
• Imipenem: Primaxin, Imipenem/Cilastatin Sodium
• Isoniazide: Nydrazid, Isoniazid
• Levofloxacin: Levotas, Levoflox
• Meropenem: Meronem, Meropenem Trihydrate
• Midazolam: Dormicum, Midazolam Hydrochloride
• Moxifloxacin: Moxicip, Avelox
• Nitrazepam: Mogadon, Nitrazepam
• Sodium Para-aminosalicylate: Paser, Sodium Para-aminosalicylate
• Pentazocine: Fortwin, Pentazocine Lactate
• Prulifloxacin: Quisnon, Prulifloxacin
• Pyrazinamide: Pyzina, Pyrazinamide
• Rifabutin: Mycobutin, Rifabutin
• Rifampicin: Rifampin, R Cinex
• Sparfloxacin: Sparquin, Zagam
• Thiacetazone: Conteben, Thiacetazone
• Tramadol: Tramazac, Ultram Zolpidem: Ambien

Hope above information is helpful to you…  
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