Routine checks for spurious drugs by drug inspectors

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

Drugs Control Department

Karnataka 

https://chat.whatsapp.com/IECdk7yCsmJ9kSNOo7Tx0k

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.

https://chat.whatsapp.com/IECdk7yCsmJ9kSNOo7Tx0k

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.

PCI to integrate pharmacists' database with Healthcare Professional Registry

Gireesh Babu, New Delhi Saturday, November 23, 2024, 08:00 Hrs  [IST]

The Pharmacy Council of India (PCI) has sought all the pharmacists who don't have the ABHA (Ayushman Bharat Health Account) number to attain a number and ensure registration with the DIGI-PHARMed profile with the ABHA number on immediate basis, as part of its efforts to integrate the pharmacists' list with the Healthcare Professional Registry (HPR). The Council is in the process of verification of all registered pharmacists on the DIGI-PHARMed portal in order to integrate pharmacists with the HPR, and asked all the pharmacists to consider certain action points in order to equip the Council for a smooth integration. "All registered pharmacists are requested to verify their DIGI-PHARMed profile with the ABHA Number on immediate basis. The said verification must be completed within the timeline of 45 days from the date of issuance of this circular," said the Council in a communication to all registered pharmacists. "Failing to this, the pharmacist's profile will be disabled for any further usage on the DIGI-PHARMed portal," it added. In case of new registration, pharmacists must ensure to verify their account with the ABHA number at the time of registration and without verification of the profile with this number will be considered as incomplete registration. If the pharmacists don't have the ABHA number, it is directed to create the ABHA number using Aadhar before initiating the process or the registration of DIGI-Pharmed portal. The Council also requested to all the pharmacy institutions as well to check that all the faculty in their institutions are having the ABHA verified profiles and notified that during the Standard Inspection Format (SIF) applications and for further reference, only ABHA verified profiled of faculty will be considered by the Council from 2025-26 academic session, it added. It also directed all pharmacists that they must ensure that the documents uploaded to the portal while registering are authentic and validated. "If the Council discovers at any stage that any documents submitted during the registration process are incorrect, the respective profile of those pharmacists will be blacklisted," said the Council. In case of any inconvenience or technical issues, the pharmacists or the institutions can share the issues over email to the Council or reach out over telephone, it added. Healthcare Professionals Registry is a comprehensive repository of registered and verified different system of medicines (modern medicine, dentistry, Ayurveda, Unani, Siddha, Sowa-Rigpa, Homoeopathy) and nurses practitioners delivering healthcare services across India.  The ABHA number will be used for the purposes of uniquely identifying persons, authenticating them, and threading their health records (only with the informed consent of the patient) across multiple systems and stakeholders The repository is part of the Ayushman Bharat Digital Mission (ABDM), which empowers healthcare professionals to be part of India’s digital health ecosystem through a unique healthcare professional ID. With last mile coverage, people will be able to interact with healthcare practitioners or vice versa. Healthcare professional profile visible in the ABDM ecosystem is verified and authorised to practice medicine in the country. The HPR ensures that healthcare practitioners suitably trained and qualified to practice medicine with competence and ethical conformity are allowed to register with the HPR.

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)

https://chat.whatsapp.com/Iili8jkCHeYJYi3x89OPuF

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

https://chat.whatsapp.com/Iili8jkCHeYJYi3x89OPuF

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.

https://chat.whatsapp.com/Iili8jkCHeYJYi3x89OPuF

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.

Pharm D course introduction and D Pharma course closure is Propaganda !!!

I don't understand why D. Pharma course is being removed as minimum qualification for registration to practice Pharmacy in India. 

They say due to corruption. (Propaganda)

But I have seen corruption and malpractices happening at higher education as well. 

1)PhD and PharmD students/interns publishing their names in scientific journals for research articles in which they have not done anything and just paid asked amount to the principal researcher so that their name get added in the research article as co-authors or co-researchers for publishing in scientific journals.

2)illogical sequence of subjects taught at colleges with these newly started courses.

3)Renting of license will continue even on Pharm-D ( doctor of pharmacy) degree.

4)To make minimum qualification for a registered pharmacist to do pharmacy practice in India, Pharm-D degree rather than D.Pharm ie. to replace the state's diploma of pharmacist.

Instead of updating and upgrading the syllabus of D.Pharm, what the policy makers have done is that they have created a new course named Pharm.D/Pharmd(PB) and obvious plan is to make it the minimum qualification for a registered pharmacist to do pharmacy practice in India.

Why create so much confusion, why malign the integrity of Pharmacy field. They could have retained the D.Pharm course and should have made neccessary changes in the syllabus and duration of D.Pharm, so that the minimum qualification for a registered pharmacist to do pharmacy practice in India remain D.Pharm and no need to replace the state's diploma of pharmacist. 

Just imagine if M.B.B.S course is replaced by some other course which is made minimum qualification for a registered physician to do medical practice in India.

And then they call themselves Pharma Expert or Drug Expert. What a pity situation ?

Pharmacare

Pharmacare is a Canadian proposal for a publicly funded insurance program for medications, similar to Medicare for health insurance. Limited pharmacare programs exist in the provinces of Ontario, Manitoba, and British Columbia. Multiple organizers and commenters have advocated a pan-Canadian pharmacare program to complement the existing health system, but the precise model for implementation is unclear.

Prime Minister Justin Trudeau talks about universal access to contraceptives and diabetes medications at Women's College Hospital in Toronto

In 2019, Prime Minister Justin Trudeau promised to implement pharmacare if re-elected. In February 2024, the NDP and Liberals reached an agreement on proposed draft legislation for a pharmacare program. The proposed program would create a single-payer system to cover expenses for contraceptives and diabetes medication in the first phase, with a designated budget of $1.5 billion. Subsequent phases would develop a national formulary and national purchasing plan, at an estimated cost of $38.9 billion for the 2027/28 fiscal year. The government tabled Bill C-64 titled An Act respecting pharmacare in 2024, which passed on October 10, 2024. The Canadian Agency for Drugs and Technologies in Health (CADTH) was revamped into Canada's Drug Agency, tasked with creating a formulary and a national purchasing plan.