Sch K amendment - Has these Objectives been Achieved?

Sch K amendment - Has these Objectives been Achieved?

The amendments to Schedule K of the Drugs and Cosmetics Rules, 1945, introduced significant changes to streamline drug regulations and accessibility. Here’s a comparative summary of the situation before and after the amendment:

👉Before the Amendment

1. Applicability and Scope:

Schedule K exempted certain classes of drugs and circumstances from specific provisions of the Drugs and Cosmetics Act, such as licensing requirements.

Focused primarily on traditional practices like home remedies, medicines for medical professionals' personal use, and drugs distributed under government programs.

2. Community Pharmacist Role:

Limited emphasis on the active role of community pharmacists in drug dispensing.

Drugs like antimalarials, contraceptives, and certain public health program-related medications were exempt from licensing under specific distribution schemes.

3. Challenges:

Regulatory gaps led to potential misuse and lack of uniformity in drug dispensing.

Limited coverage for modern healthcare needs.

The evolving role of pharmacists was not well-integrated.

👉After the Amendment

1. Expanded Scope and Clarity:

The amended Schedule K included clearer definitions and expanded exemptions to include new healthcare settings, such as telemedicine, e-pharmacies, or alternative delivery mechanisms.

Streamlined processes for government health programs.

2. Enhanced Role of Pharmacists:

Stronger emphasis on the role of qualified pharmacists in dispensing drugs exempted under Schedule K.

More robust inclusion of community pharmacists to bridge healthcare access gaps.

3. Strengthened Public Health Initiatives:

👉Better alignment with national health priorities, including immunization, TB control, and other public health programs.

Rationalized exemptions for drugs used in specific national healthcare programs, reducing regulatory delays.

4. Digital and Telemedicine Integration:

Eased rules for modern dispensing methods, recognizing the role of digital healthcare and online pharmacies in delivering medicines, especially in remote areas.

5. Regulatory Compliance:

👉Tighter monitoring of exempted drug categories to reduce misuse or diversion.

Improved documentation and accountability measures.

👉Impact of the Amendment

Improved Accessibility: Rural and underserved regions benefited from greater accessibility to essential medicines without unnecessary bureaucratic hurdles.

Pharmacist Empowerment: Elevated pharmacists’ status as critical stakeholders in ensuring safe drug delivery and patient counseling.

Adaptation to Modern Healthcare Needs: Regulatory provisions evolved to accommodate digital healthcare platforms, telemedicine, and innovations in drug distribution.

These changes have harmonized regulations with the dynamic healthcare landscape while ensuring public safety and enhancing pharmacists' contributions to patient care.

Has this not made 'Pharmacist' dispensable/Replaceable and Substitutable?

PCI has a right to verify and demand reversal if it is found curtailing the scope of the profession and professionals

POV : Bhagwan PS

The "Schedule K of the D&C Act," 1948, which allows the Indian Doctor to dispense ,Sell Medicine without any Drug Licence .... Which is a Criminal offence in All the countries of the world... In older times when there were not enough Pharmacy/ Chemist shop, and the shops closed at 8 pm... the Doctors and Clinics who needed Medicine in case of emergencies were allowed to keep emergency medicine for patients, and a amendment was made in the D&C act... Called the Schedule k... Which allows the Indian Doctor to keep Medicine at his clinic/ nursing home... without any Drug Licence... But now with availability of 24 hrs Pharmacy/ Chemist shop... This rule should have been abolished as elsewhere in rest of the world... Where a Doctor cannot keep/ sell even a paracetamol from his Clinic/ nursing home.... But in India, since the Pharma lobby is controlled by the IMA... This law has not been changed... And this is the reason which even a Quack can be allowed to keep Medicine in his clinic and dispensing and loose Medicine are allowed in India... The IMA is to blame for mushrooming of the Quacks and even the misuse of Schedule k, of the D&C Act, 1948 by The Nursing Homes, Clinic and Hospital ...  Leaving the pharmacist to just use the "Pharmacist License" to Open a Chemist/ Pharmacy shop ....A Pharmacist who is an expert in Medicine/ Drug in India , is left just with a work to pass on the Medicine to the patient as a salesman... While in rest of the world, a Patient looks forward to getting expert advice by a Clinical Pharmacist on the correct dosage and per kg body wt. Calculated exact dosage schedule ( in case of Critical medicines),  precautions, monitoring and reporting any side effects, adverse effects of a Drug prescribed by a Doctor. Across the world, No person except the Pharmacist can dispense, sell or guide anyone on the Medicine/ Drug.

GSR 220 cancellation request

कोरोना काल में दवा बिक्री को लेकर जारी अधिसूचना को रद्द करे सरकार

भागलपुर केमिस्ट एंड ड्रगिस्ट एसोसिएशन के महासचिव प्रशांत लाल ठाकुर ने कोरोना संक्रमण को रोकने के लिए जारी अधिसूचना जीएसआर 220 (ई) को रद्द करने की मांग की है। उनका कहना है कि डिजिटल प्लेटफार्म बिना वैध..

भागलपुर, वरीय संवाददाता कोरोना संक्रमण को रोकने के लिए दवा बिक्री को लेकर जारी अधिसूचना जीएसआर 220 (ई) को भागलपुर केमिस्ट एंड ड्रगिस्ट एसोसिएशन के महासचिव प्रशांत लाल ठाकुर ने रद्द किए जाने की मांग की है। उन्होंने कहा कि ये अधिसूचना कोरोना काल में स्थानीय दवा विक्रेताओं को इमरजेंसी के आधार पर स्थानीय दवा दुकानदारों को घर-घर दवा पहुंचाने की सुविधा देने के लिहाज से जारी की गई थी। लेकिन मौजूदा काल में कई डिजिटल प्लेटफार्म इस अधिसूचना का दुरुपयोग कर बिना किसी वैध प्रिस्क्रिप्शन के घर-घर दवाई पहुंचा रहे हैं। जो रोगाणुरोधी प्रतिरोध, नशीली दवाओं के दुरुपयोग और स्वचिकित्सा जैसी समस्याओं को जन्म दे सकती है। ऑनलाइन दवा बेच रहे प्लेटफार्म का ध्यान केवल उनके अपने मुनाफे पर है। यदि इस अधिसूचना पर रोक नहीं लगती है तो ये ऑनलाइन कारोबार जनता की सेहत के लिए खतरे का सबब बन सकता है। ऐसे में इस अधिसूचना को रद्द कर दवाओं की बिक्री और वितरण के लिए प्रिस्क्रिप्शन और अन्य नियामक प्रावधानों का कड़ाई से पालन कराया जाय. 

Reality against Myths (PCI book)😢What PCI has to say?

Reality against Myths (PCI book)😢

What PCI has to say? 

Drugs Control officers can not take action for non compliance with  PPR or Pharmacy Act. 

Incidentally, the term " Pharmacy" contemplated under Rule 65(15)(c) refers to establishments complying with Schedule N of Drugs and Cosmetics Rules. For records, establishments possessing license for " Pharmacy" in compliance with Schedule N is in single digits, may be TWO or THREE in the entire State of Karnataka. Even these two or three need not comply with PPR. They have to comply with Schedule N.

Let me also clarify that the medical shops where D.Pharm holders are engaged and whose number in the State is more than 30000 and for whose upliftment you are fighting for are referred as " Chemists and Druggists " under Rule 65(15)(c).

 

I have been saying PPR has no legal sanctity. None has bothered to look into this and everyone harps on implementing PPR.  

Lastly, :

1. To implement SECTION 42 of Pharmacy Act separate authority is contemplated. State Councils are accountable if they have not appointed inspectors to implement Section 42 for decades.

2. Your observation Drugs regulatory together with State pharmacy Council can make the system water tight for violators is a wishful thinking."...

Unquote:

... 😢

Attn:#PCI

This has happend is happening because:

1.PCI administrators do not know how to administer the office.

2. PCI do not follow Government Office Manual and PCI is being managed without due documentation and #Accountability, otherwise how the President's resignation letter was accepted without scrutiny and someone takes over without any fuss.

4.PCI is playing irresponsibly with the life of millions of youngsters leaving them Blindfold!

5. PCI is  luxurious jambooree to the members to make family trips.

Poor pharmacists 😢

POV : Bhagwan PS

Routine checks for spurious drugs by drug inspectors

Routine checks for spurious drugs by drug inspectors from the desk of

Drugs Control Department

Karnataka 

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Inspections conducted by drug inspectors often reveal whether a medicine is spurious or misbranded through rigorous sampling and laboratory testing.

during routine checks at manufacturing units, pharmacies or distribution channels, inspectors collect samples of medicines, which are sent to government-approved laboratories for analysis.

“If a medicine fails to meet the prescribed quality standards set by regulatory authorities such as the Drugs Controller General of India (DCGI), contains incorrect or harmful ingredients, or is falsely labelled, it is classified as spurious. Similarly, if the labelling is inaccurate, misleading or fails to adhere to regulatory guidelines, the medicine is marked as misbranded. Once identified, the drugs are labelled accordingly, and immediate action is taken to prevent their distribution and sale,” the official said.

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These medicines pose significant risks to public health as they can lead to ineffective treatment, adverse reactions and harm antibiotic resistance, the official said, adding that regulatory authorities, on a regular basis, detect spurious or misbranded medicines through inspections, testing, consumer complaints, and monitoring of manufacturing processes.

Self inspection / audit of medical store / Drug sale unit (Retail and / or Wholesale units)

Self inspection / audit of medical store / Drug sale unit (Retail and / or Wholesale units)

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Self audit of the medical store is important

Self audit of the medical store is suggested for the assessment of the working of the firm, whether the firm is working as per the Drugs and Cosmetics Act 1940 and Rules framed thereunder or not.

It should be conducted periodically by the Prop. / Partners / Directors and / or Regd. Pharmacist or Experience Person of the firm.

The improvement or rectification should be done immediately as per the observations during self audit of a medical store.

Here is the checklist for self audit for medical store:

Pharmacist Medical Store

Picture: Wikimedia.org

Self inspection / audit of medical store / Drug sale unit (Retail and / or Wholesale units)

Abbreviations:

RSDL: Retail Sale Drugs License

WSDL: Whole Sale Drugs License

RP: Regd. Pharmacist

EP: Experience Person

RMP: Regd. Medical Practitioner

DCO: Drugs Control Officer

NSQ: not of std. quality

CS: Civil Surgeon

TB: Tuberculosis

Checklist for Self inspection / audit of Drug sale unit Retail and / or Wholesale units Date …………………..Done by ………………

1. Distt. 

2. Name of the firm 

3. Address of the firm 

4. License No. of the firm 

5. License granted on Dated ………..

6. Validity of the license Dated…………

7. License Retention fee submitted (If due) Yes / No 

(Submit license retention fee within time)

8. Proof of license Retention fee submission kept. Yes / No

(Proof of License retention fee must be kept in record)

9. Constitution of the firm: Proprietorship / Partnership / Pvt. Ltd. / Ltd firm

10. Any change in constitution. Yes / No

11. Have you applied for new license due to change in constitution in time (If constitution changed) Yes / No / NA

(Apply for change in constitution within 90 days)

12. Name(s) of Prop. / Partners / Directors of the firm 

13. Name of the responsible person of the firm 

14. Have you changed the premises without obtaining fresh license. Yes / No

(Obtain fresh license before changing the premises)

15. File regarding correspondence with Drug department is maintained Yes / No

(Maintain file of correspondence drug department. e.g. Letters, Notices and circular etc.)

16. Whether licenses of the firm ever suspended or partially cancelled. Yes / No

(Obey Drugs and Cosmetics Rules)

17. Whether sign board of name of the firm displayed. Yes / No

(Display sign board with name of the frim)

18. Whether “Chemist and Druggist” written on the sign board. Yes / No

(“Chemist and Druggist” must be written on sign board)

19. Whether Drug License displayed at a prominent place. Yes / No

(Display drug license at the prominent place)

20. Name of Regd. Pharmacist (RP / EP) of the firm

21. Regn. Number of RP 

22. Validity of Regn. of RP 

(Validity of Regn. Certificate of RP must be up to date) 

23. Whether Regn. Certificate of RP displayed. Yes / No

(You should display Regn. Certificate of RP)

24. Joining date of RP 

25. Whether any change in RP. Yes / No

26. Resignation date of RP (If resigned) 

27. Whether new RP appointed (If resigned)Yes / No

28. Whether information of change in RP has been given to department within one month. Yes / No

29. If yes, date of appointment of new RP 

30. Name of new RP

31. Regn. Number of RP 

32. Validity of Regn. of RP 

33. Whether Gap is there between resigning and joining of new RP, if any No, if yes ……days

34. If yes, sale /purchase of drugs between gap period. Yes / No

(No sale / purchase of drug be done in the absence of RP)

35. Whether dust free environment is maintained in the premises. Yes / No

(Keep your premises neat and clean)

36. Whether purchase record of drugs is maintained properly. Yes / No

(Maintain purchase record of every drug properly)

37. Whether purchase record is maintained in chronological order (Maintain purchase record in chronological order) Yes / No

38. Whether drugs are purchased from licensed dealers. Yes / No

(Always purchase the drugs from licenses dealers only)

39. Whether purchase invoices bear all the mandatory details. Yes / No

(Purchase invoice should have all mandatory details of drug)

40. Whether drugs are being sold under the personal supervision of RP. Yes / No

(Sale of drugs must be in the personal supervision of RP only)

41. Whether drugs are being sold on the prescription of RMP. Yes / No

(Sell the drugs on the prescription of a RMP)

42. Whether substituting the prescription of RMP. Yes / No

(Do not substitute the prescription of RMP)

43. Selling of drugs on price more than MRP. Yes / No

(Do not sell the drugs on the price more than MRP)

44. Sale records of drugs maintained. Yes / No

(Maintain sale record of the drugs)

45. Sale records maintained in legible manner. Yes / No

(Maintain sale record of the drugs in legible manner)

46. Name and address of prescriber mentioned. Yes / No

(Mention name and address of prescriber)

47. Name and address of patients mentioned. Yes / No

(Mention name and address of patient)

48. Sale record is having all other mandatory details ? Yes / No

(sale record of drugs should have all mandatory details)

49. Sale invoice signed by RP. Yes / No

(sale invoices must be signed by RP)

50. Schedule-H1 register maintained. Yes / No

(Maintain Schedule-H1register)

51. Full time electricity supply. Yes / No

(Full time electricity supply must be ensured to maintain desired temperature of the drugs)

52. If not, Generator maintained. Yes / No

(Full time electricity supply must be ensured to maintain desired temperature of the drugs)

53. Direct Sun light on the drugs. Yes / No

(Drugs should not be exposed to direct sunlight)

54. Refrigerator maintained. Yes / No

(maintain adequate gap between wall and refrigerator)

55. Whether adequate gap is there between wall and refrigerator. Yes / No

(maintain adequate gap between wall and refrigerator)

56. Refrigerator is in working condition. Yes / No

(Refrigerator must be in working condition)

57. Temperature of refrigerator is maintained. Yes / No

(Temperature of refrigerator must be maintained)

58. Stocking the drugs in refrigerator which do not require storage of refrigerator. Yes / No

(Do not stock drugs in refrigerator which do not require storage of refrigerator)

59. Stocking the drugs in refrigerator which require storage of refrigerator. Yes / No

(Stock drugs in refrigerator which require storage of refrigerator)

60. Whether food items are stored in refrigerator ? Yes / No

(Do not stock food items in refrigerator)

61. Whether oily injections are stored in refrigerator ? Yes / No

(Do not stock oily injections in refrigerator)

62. Switching off the refrigerator in the night. Yes / No

(Do not switch off the refrigerator in the night and maintain desired temperature of the drugs)

63. Air conditioner / Cooler 

(Do not install cooler, however air conditioner is advisable to maintain the temperature of drugs) 

64. Stocking the drugs in its original containers. Yes / No

(Always stock the drug in the original container of that drug)

65. Stocking the drugs in racks (Retail) raised platforms (Wholesale) Yes / No

(Stock the drugs in racks or raised platforms)

66. Stocking the drugs on floor. Yes / No

(Do not stock the drugs directly on the floor)

67. Homeopathic medicines stocked separately. Yes / No

(Stock the homoeopathic medicines separately)

68. “Homeopathic medicines” written on the rack. Yes / No

(write “Homeopathic medicines” on the rack)

69. Ayurvedic medicines stocked separately. Yes / No

(Stock the Ayurvedic medicines separately)

70. “Ayurvedic medicines” written on the rack. Yes / No

(write “Ayurvedic medicines” on the rack)

71. Veterinary drugs stocked separately. Yes / No

(Stock the Veterinary drugs separately)

72. “Veterinary drugs Not for human use” written on the rack. Yes / No

(write “Veterinary drugs Not for human use” on the rack)

73. Expiry drugs found stocked. Yes / No

74. If yes, expiry drugs kept separately. Yes / No

(Stock Expired drugs separately away from the trade stock)

75. “Expired dated drugs Not for Sale” written on the rack. Yes / No

(Write “Expired dated drugs Not for Sale” written on the rack)

76. Correspondence with dealers regarding expired drugs. Yes / No

(Correspondence with dealers regarding expired drugs must be done)

77. Sch-X drugs found stocked. Yes / No

(License must be obtained before dealing in Schedule-X drugs)

78. “Physician samples not for sale” found stocked. Yes / No

(Do not stock and sell “Physician samples not for sale”)

79. “Hospital supply drugs not for sale” found stocked. Yes / No

(Do not stock and sell “Hospital supply drugs not for sale”)

80. Misuse of Intoxicating drugs. Yes / No

(Never sell intoxicating drugs without prescription of a RMP, it may be misused)

81. Vet. Oxytocin Injection found stocked. Yes / No

(Stock and sell Vet. Oxytocin Injection in single blister pack only)

82. Diclofenac Injection for veterinary use found stocked. Yes / No

(Do not Stock and sell Diclofenac Injection for veterinary use and it should not more than 10ml vial)

83. MTP Kit 

(MTP kit is to be used under the supervision of a service provider and in a medical facility as specified under MTP Act 2002 and MTP Rules 2003) 

84. Sildenafil Tablets 

(Sildenafil tablets are to be sold on the prescription of Urologist / Psychiatrist Endocrinologist / Venereologist / Dermatologist only) 

85. Are Infant foods displayed. Yes / No

(Infant foods should not be displayed)

86. ‘Banned Nail Polish Remover’ found stocked. Yes / No

(Do not stock and sell ‘Banned Nail Polish Remover’)

87. “Banned drugs” found stocked. Yes / No

(Never stock and sell ‘Banned drugs’)

88. Whether you sell TB drugs. Yes / No 

89. If Yes, whether you are reporting about TB patient to Civil Surgeon. Yes / No

(You should report details of the TB patient to CS)

90. “Without invoice drugs” found stocked. Yes / No

(Purchase of drugs with invoice only)

91. Whether Essential Narcotics Drugs stocked ? Yes / No

92. If yes, whether you have obtained license on Form-24 ? Yes / No

(Obtain license on Form-24 before stocking and selling of Essential Narcotics Drugs)

93. Dustbin kept for “Clean India Project”. Yes / No

(Keep a dustbin and keep India Clean)

94. Date of last inspection done by Drugs Control Officer 

95. Whether samples have been withdrawn by DCO. Yes / No

96. What was the result of sampled drug. Standard / NSQ

97. Copy of last inspection kept. Yes / No

(Copy of inspection report must be kept)

98. Hydroxychloroquine is in Schedule-H1 now. To download the notification, click here.

(Maintain schedule-H1 record for this drug)

99. 2ply, 3ply surgical masks, N95 masks and hand sanitizers are under Essential Commodities Act 1955 were upto 30–06–2020. To download the notification, click here.

100. Retail prices of 2ply, 3ply surgical mask and Hand sanitizer werefixed upto 30–06–20202 ply surgical mask- not more than Rs. 8/- per piece 3ply surgical mask- not more than Rs. 10/- per piece Hand sanitizer — Rs. 100/- per bottle of 200ml. To download the notification, click here.

101. Is sale license is required for stocking and selling of hand sanitizer ? Yes

102. Is sale license is required for stocking and selling of hand cleanser / Rub / wash ? No

103. Door step delivery of drugs. Govt of India has issued notification No. G.S.R. 220 (E ) dt. 26–03–2020 regarding the door step delivery of drugs. To download the notification, click here.

104. Sale of some drugs without prescription of RMP and without supervision of Registered Pharmacist. Drugs which are not covered under Schedule H, H1, G, X, nRx, can be sold without prescription of RMP and without supervision of Registered Pharmacist.

105. Whether you have installed CC Camera at your premises ? Yes / No

Sign

Date

Name

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Prepared by

Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

We have provided some mandatory duties of Retail chemist / Medical store / Pharmacy, if you don’t follow these duties you may be in trouble in future. Follow these duties for a smooth and peaceful business and have sound sleep. Let’s have a look on these duties:

We have provided some mandatory duties of Retail chemist / Medical store / Pharmacy, if you don’t follow these duties you may be in trouble in future. Follow these duties for a smooth and peaceful business and have sound sleep. Let’s have a look on these duties:

1. Display your valid license with photograph of pharmacist issued under Drugs and Cosmetics Act by the competent Licensing Authority on a prominent place clearly visible to the customers at the Medical Store / Pharmacy.

2. Display the registration certificate of your pharmacist having his / her photograph on a prominent place clearly visible to the customers at the Medical Store / Pharmacy.

3. Always purchase the drugs from the authorized source having valid Wholesale Drug License.

4. Always place the purchase order to the wholesaler / distributor on a signed written format with name, quantity and company of the drug.

5. Always compare the quantity, Batch no., Expiry, Name of company of purchased drug with received invoice.

6. Always stock the drugs in proper storage conditions as per Rule-96, Schedule-P of Drugs and Cosmetics Act and as mentioned on the label of the drugs.

7. Never destroy / throw the secondary packing unless the complete quantity of drug is sold as the secondary packing / outer printed carton etc. are having various important information and also required for proper storage.

8. Always stock veterinary drugs in a separate rack / cupboard / box that too in the rear part of shop having a proper label “Veterinary drugs not for human use“

9. Always keep expired drugs in a separate box/cupboard in a separate corner having proper label in red colour “Expired: not for sale“

10. Never keep your food articles, drinking water and oily injections e.g. Progestrone, Nandrolone, Decanoate etc. in a refrigerator in which drugs are stocked. Never switch off your refrigerator during night time. Also avoid stocking drugs on or in the back of the refrigerator as refrigerator emits heat which may affect the quality / potency of drug.

11. Never keep / stock drugs exposed to direct sunlight as it may affect the quality / potency of drug.

12. Always keep the record required for Schedule H1 drugs as per the provisions of the Drugs and Cosmetics Act.

13. Never refuse to issue cash memos for the drug to the customers.

Format of the cash / credit memo should be as per provisions of Rule 65 of Drug and Cosmetics Rules and must be having information:

    Name and address of shop,

    License No.,

    GST no. (if required),

    Name & address of Customer / Patient,

    Name & address of Prescriber with Registration no. of Registered Medical Practitioner (RMP),

    Sr. No. of cash / credit memo

    date of cash / credit memo

    Quantity of drug,

    Name of drug,

    Batch no. of drug,

    Expiry date of drug,

    Name of manufacturing company,

    Subtotal,

    Grand total

    Signature of Registered Pharmacist.

14. Always issue cash or credit memos in chronological order, and never leave any cash or credit memo blank in between in case it is mishandled.

15. Always educate / advise the customer / patient regarding:

    Dose of the drug

    Method of consumption of the drug

    The side effects of the drug

    The contraindications of the drug

16. Always stock Schedule X drugs in a separate cupboard / almirah with lock and key and keep their record as required under provisions of Drugs and Cosmetics Act.

17. Never sell the drugs containing Narcotic and Psychotropic Substances (NDPS Act) which are capable of being misused as Medical Intoxicants without the valid prescription of a Registered Medical Practitioner (RMP).

18. Never sell a Schedule H, H1, X drug without the prescription of a Registered Medical Practitioner (RMP) and without issuing cash memo and keep the required record for Schedule H1 & X drugs as per provision of Drug and Cosmetics Act.

19. Always sell the drugs in the supervision of Registered Pharmacist as the Registered Pharmacist is the custodian of drugs and responsible for purchase, stocking, sale and maintenance of quality of drug.

20. Never purchase, stock and sell a drug which you cannot consume yourself and for your family when required.

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Issued by: FDA Haryana, India

Stricter enforcement over Antibiotics use

In India, doctors and pharmacists are required to follow certain guidelines to ensure the responsible use of antibiotics:

Doctors must provide a reason

Doctors are required to write the reason for prescribing antibiotics to patients. This is to ensure that antibiotics are used wisely and only when necessary. 

Pharmacists must sell antibiotics with a prescription

Pharmacists are required to sell antibiotics only with a prescription from a qualified doctor. Antibiotics are listed in Schedule H of the Drugs and Cosmetics Rules and are not to be sold over-the-counter. 

Stricter enforcement

The government is enforcing stricter rules to ensure that antibiotics are only sold with a prescription. 

Antibiotic misuse and overuse is a major driver of antimicrobial resistance (AMR), which makes infections harder to treat and increases treatment costs. In 2018, the Indian government launched the National Action Plan on Antimicrobial Resistance to improve awareness and promote responsible antibiotic use.