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.

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)

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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.

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.

Policy & Regulation DTAB recommends amendment of Rule 64 related to qualification of competent person for wholesale license Gireesh Babu, New Delhi Wednesday, October 23, 2024, 08:00 Hrs  [IST] The Drugs Technical Advisory Board (DTAB) has once again recommended the finalisation of the amendment of Rule 64 of the Drugs Rules, 1945, to restrict the qualification of the competent person eligible for holding the license for wholesale of drugs under Form 20B and 21B. The Board, in its latest meeting held in August, observed that the amendment was issued through a draft notification in December, 2016, after an earlier recommendation, but has not been finalised. The Rule 64 specifies the conditions to be satisfied before a licence in Form 20, 20B, 20F, 20G, 21 or 21B is granted or renewed. The second proviso to sub-rule (2) of this Rule specifies the requirements of the area and the qualification of the competent person for grant of licence in Form 20B and 21B. The existing rules specifies that the competent person should be a registered pharmacist, or one who has passed the matriculation examination or its equivalent examination from a recognised Board with four years' experience in dealing with sale of drugs, or one who holds a degree of a recognised university with one year's experience in dealing with drugs. The Board was considering a proposal to amend this proviso to restrict the qualification of the competent person to a person with pharmacy background only, such as D.Pharmacy, B.Pharmacy, M.Pharmacy and Pharm.D. As per the proposal, clause (b) and (c), which are related to other qualifications such as matriculation examination or its equivalent examination from a recognised board with 4 years' experience in dealing with sale of drugs, or degree of a recognised university with one year experience in dealing of drugs should be deleted from the Rules. The matter was earlier considered in a meeting held by the Board in August, 2015, and recommended that the clause (b) and (c) of the second proviso may be deleted and a protection clause may also be provided that the academic qualification shall not apply to the persons already registered prior to the date of final notification. A draft notification in this regard was published in December, 2016, but there were several issues raised from the stakeholders, due to which the said draft notification could not be finalised. The Board also said that "there was a concern about its desirability and accessibility." After examination of the stakeholders comments, the Central Government requested the Board to furnish comments and inputs in the matter. The DTAB, after looking at the matter, "again recommended for the finalisation of the Draft" for amendment of the Rule 64, "to strengthen the supply chain for ensuring the quality, safety and efficacy of drugs." It may be noted that the Central Drugs Standard Control Organisation (CDSCO) has constituted a committee for revisiting the Rule 64, under Part VI of the Drugs Rules, pertaining to sale of drugs other than homoeopathic medicines "with regards to the present scenario". The conditions of Rule 64 prescribes the conditions to be satisfied before a license in various forms related to sale of drugs is granted. The Drugs Consultative Committee (DCC), which advises the Centre and the States on the matters that requires uniform implementation across the country, has also recently asked the committee formed by the CDSCO to revisit the Rule 64 of Drugs Rules, 1945, and place its report before the DCC for further discussion and consideration.

PCI offers continuing education and skill development programmes to pharmacists

Our Bureau, New Delhi Wednesday, October 23, 2024, 08:00 Hrs  [IST]

The Pharmacy Council of India (PCI) has informed all State Pharmacy Councils that the council has initiated continuing education programmes and skill development programmes to improve the skill sets of the pharmacists across the country. The information has been passed to the State Councils to utilise the initiatives to improve the quality of manpower in the states. PCI has joined hands with Life Sciences Sector Skill Development Council (LSSSDC) for skill development and entrepreneurship under funding support from Pradhan Mantri Kaushal Vikas Yojana for Upskilling and Certification Programme of LSSSDC in Life Sciences Sector. The project has a total of 26,500 seats for the registered pharmacists for upskilling and certification by LSSSDC. This is a good opportunity for State Pharmacy Councils in the Southern Region to up-skill and certify the registered pharmacists for their future growth and enhance the skills for efficient performance in pharmacies. Initially, the project will start from southern states. Mandatory 30 hours including four hours for programme orientation and mock assessment practice, along with two-three hours for mandatory assessments and daily training hours is minimum two hours and maximum eight hours. This certificate will be issued after completion of course. Certificate is valid for renewal of registration under CEP, under regulation 4.2 of Pharmacy Practice Regulations, 2015, it added. Besides, the Council has launched an online certificate course on Rational Use of Medicines for registered pharmacists, under the continuous education programme, in collaboration with Translational Health Science and Technology Institute (THSTI). This is to enable the registered pharmacists to make the community aware to use the drugs rationally. This certificate will be issued after completion of course and is valid for renewal of registration under CEP, under the provisions of Pharmacy Practice Regulations, 2015.

As per Circular issued by CBIC, the return of expired medicine must be treated as a fresh supply. The retailer or wholesaler can return the expired medicine to the manufacturer. Issuance of Invoice is mandatory for the return of such expired medicine.

When expired medicines are returned to a wholesaler, they are treated as a fresh supply and are usually destroyed by the manufacturer:

• Manufacturer destroys the goods

  The manufacturer reverses the ITC that was used when the expired goods were received. The ITC that needs to be reversed is the one used when the goods were returned, not the one used when they were manufactured.
• Manufacturer purchases the goods

  If the goods are deemed a fresh supply, the manufacturer or wholesaler will purchase them. 

• Here are some other things to know about returning expired medicines:

The retailer or wholesaler must issue an invoice for the returned medicine. The invoice should include the value of the medicine at the rate it was originally purchased.

 An unregistered person can return expired goods by issuing a commercial document without charging tax.

A reverse distribution company can be used to coordinate the return process. The company sorts and batches the products, calculates the return credit value, and sends the credit to the pharmacy. 

• Expired medicines can be less effective or risky because their chemical composition or strength may have changed. Some expired medications can grow bacteria, and sub-potent antibiotics can fail to treat infections.  

The Drugs Controller General of India (DCGI) is planning to amend the Medical Devices Rules, 2017 to include a provision for quality requirement for non-sterile and non-invasive medical devices such as thermometers, stethoscopes, elastic bandages, and non-electrical wheelchairs.

The Drugs Controller General of India (DCGI) is planning to amend the Medical Devices Rules, 2017 to include a provision for quality requirement for non-sterile and non-invasive medical devices such as thermometers, stethoscopes, elastic bandages, and non-electrical wheelchairs.

Currently, there is a provision for licence exemption to manufacture and import Class A medical devices (non-sterile products) for marketing in the country and conformance to quality management system for manufacturing of such medical devices is not included in the existing rules.

The matter was discussed in a meeting of the Drugs Technical Advisory Board (DTAB), the country’s top technical advisory body on drugs and medical devices, held last month

For existing institutions offering a Bachelor of Pharmacy (B.Pharm) program, approval from the Pharmacy Council of India (PCI) is mandatory, but approval from the All India Council for Technical Education (AICTE) is not required: (2020) Is AICTE approval mandatory for B. Pharm? In compliance of the order dated 05.03. 2020 passed by the Hon'ble Supreme Court of India in Transferred Petitions (CIVIL) No 87-101 of 2014, for the existing institutions offering courses in Pharmacy Programme, approval of Pharmacy Council of India (PCI) is mandatory and AICTE approval is NOT required.

• PCI

  The PCI is a statutory body under the Ministry of Health and Family Welfare, Government of India. The PCI is responsible for approving B.Pharm courses and ensuring that institutions meet certain requirements, such as having adequate classrooms, laboratories, and staff facilities. 
  
• AICTE

  The AICTE is a statutory body that develops technical education in India. The AICTE created a model course curriculum for B.Pharm, which universities can use to frame their own syllabi. 

• For existing institutions that offer B.Pharm courses, approval from the PCI is mandatory, but approval from the AICTE is not.  

PCI should conduct comprehensive study on performance of pharmacy institutions: Prof GP Mohanta

Peethaambaran Kunnathoor, Chennai

Friday, October 18, 2024, 08:00 Hrs  [IST]

Since Pharmacy Council of India (PCI) is now the only regulator for pharmacy education in the country after AICTE’s discontinuation of jurisdiction over pharmacy, the PCI should conduct a comprehensive study about the importance and performances of all pharmacy institutions, and check whether they fulfill all the requirements for providing quality education, opines Prof. Guru Prasad Mohanta, former HoD at the Department of Pharmacy at Annamalai University in Tamil Nadu.

 

According to him, the majority of the private pharmacy colleges are working with poor-quality faculty members. The PCI is not providing training programmes for the beginner-teachers. When pharmacy education was under the regulation of both the PCI and the AICTE, the technical education council used to conduct orientation programmes and refresher courses for the teachers.

When the AICTE’s role was severed, these two training programmes ceased to exist, and the PCI did not want to take it forward. As a result, the fresh faculty members do not get any training programme. Mohanta said the teachers should be given training on how to teach the subjects and how to handle a classroom. They should also be updated with the latest developments in the subject also.

 

He said India has the largest number of pharmacists as well as the largest number of pharmacy colleges. At present, the domain of India’s pharmacy education includes 5,855 pharmacy education institutions, 93,336 faculty members and 360,072 students. Out of 5,855, 1,865 colleges are affiliated to various private universities and 1,911 colleges are working under state medical or health universities. Besides, there are four government universities and seven National Institutes of Pharmaceutical Education and Research (NIPERs) that run exclusive pharmacy courses. The number of pharmacy college-affiliated private universities is 24.

 

Every year, over three lakh pharmacy graduates and diploma holders are produced by Indian pharmacy institutions. But there is not an all-inclusive report of the importance, necessity and performances of these institutions available either with PCI or with any institution or any agency. Being the pharmacy education regulator, the PCI should come forward to conduct a survey study about the performances and necessity of this many pharmacy colleges functioning across India. Similarly, the study should also focus on the facilities available in each institution, and whether the college managements are complying with the norms of the pharmacy council guidelines with regard to infrastructure facilities, laboratory equipment and qualification of the teachers.

 

According to him, there are very few institutions functioning with properly qualified faculties. In the case of qualification and standard required for teachers, the PCI should amend the rules and ensure highly qualified people are playing the role of faculty members in institutions. If India has to produce well-qualified pharmacists, quality of education is a factor which can be delivered only by well-qualified teachers.

 

Going back, Prof Mohanta said, the PCI, considering the availability of sufficient qualified pharmacist workforce, the national education regulator, in 2019, put a moratorium on the opening of new pharmacy colleges for running diploma as well as degree courses in pharmacy for a period of five years from the academic year 2020-2021. However, on the intervention of college managements with high courts, the council had to withdraw the moratorium in the next academic year, and from that year on the number of institutions started to increase alarmingly. At the time of putting the moratorium, the number of pharmacy colleges in India was 3,000.

 

He pointed out that when the AICTE lost its jurisdiction over pharmacy education, it stopped all grants that were being given to pharmacy students and institutions in the form of scholarships and other benefits. He alleged further that the government assured the students of a GPAT scholarship for pharmacy students, but the PCI is not vigorously initiating steps for expediting it. 

 

In Tamil Nadu, the president of the state branch of the APTI, Dr V Sankar, and in Odisha, the principal of the Dadhichi College of Pharmacy in Cuttack, Dr Rajat Kumar Kar, have started faculty training programmes for pharmacy teachers in the absence of refresher courses by AICTE or PCI.

A staggering 39 million people worldwide could succumb to antibiotic-resistant infections over the next 25 years, according to a landmark study published in The Lancet.

A staggering 39 million people worldwide could succumb to antibiotic-resistant infections over the next 25 years, according to a landmark study published in The Lancet. This chilling projection underscores the urgent need to combat antimicrobial resistance (AMR) as a critical global health crisis. Conducted by the Global Research on Antimicrobial Resistance (GRAM) Project, the study is the first comprehensive analysis of AMR trends, outlining its alarming future impact.

Key Findings: AMR-Related Deaths on the Rise

The GRAM study reveals that over one million people died annually from AMR between 1990 and 2021. Even more concerning is the forecast for 2050, where nearly 2 million people are projected to die directly due to AMR each year—an increase of nearly 70% compared to 2022. Furthermore, AMR is expected to contribute to 8.22 million deaths annually by 2050, representing a 75% surge from the 4.71 million deaths recorded in 2022.

Age-Related Trends in AMR Mortality

• Children under five years old: Deaths declined by 50% between 1990 and 2021, yet AMR still poses a threat.
• Adults aged 70 and older: AMR-related deaths rose by over 80%, with this demographic expected to bear the brunt of the mortality burden by 2050.

While AMR deaths among young children are expected to halve by 2050, fatalities in older populations will more than double, highlighting the aging population’s vulnerability.

Global Health Implications of AMR

Antimicrobial resistance occurs when bacteria evolve and no longer respond to medications, rendering treatments ineffective. The consequences of unchecked AMR are far-reaching and devastating. AMR already claims more lives than HIV/AIDS and malaria combined, with 1.2 million direct AMR-related deaths in 2019 alone. By 2050, this figure will balloon to a total of 39 million deaths across all ages.

Geographic Disparities

AMR-related deaths will disproportionately affect regions such as:

• South Asia: Expected to account for 11.8 million deaths directly due to AMR between 2025 and 2050.
• Sub-Saharan Africa and Southern/Eastern Asia: These regions will also see significant rises in fatalities, driven by limited healthcare access and ineffective infection control measures.

Historical Data and Projections

The GRAM study analyzed 520 million records from hospital data, deathc ertificates, and antibiotic use across 204 countries and territories. Based on historical trends, AMR-related deaths have steadily increased since 1990, with 1.14 million deaths directly attributed to AMR in 2021.

AMR’s Most Common Culprits:

• Methicillin-resistant Staphylococcus aureus (MRSA): Deaths increased from 57,200 in 1990 to 130,000 in 2021.
• Carbapenem-resistant Gram-negative bacteria: Resistance to these antibiotics grew from 127,000 deaths in 1990 to 216,000 in 2021.

Without significant intervention, these pathogens and others will continue to fuel rising mortality rates.

The Urgent Need for Global Action

To mitigate the escalating AMR crisis, the study calls for a comprehensive global strategy focused on:

• Infection prevention and vaccination programs
• Minimizing inappropriate antibiotic use
• Research and development of new antibiotics targeting resistant bacteria
• Access to quality healthcare and antibiotic treatments

The Future of AMR: What Lies Ahead?

Based on current trends, AMR is expected to directly cause 1.91 million deaths annually by 2050, a stark 67.5% increase from 2021. In total, more than 39 million deaths will result directly from AMR between 2025 and 2050. However, with improved healthcare infrastructure and targeted development of antibiotics, an estimated 92 million deaths could be averted.

Key Solutions to Avert Catastrophe:

• Improved infection care: Particularly in regions like South Asia, sub-Saharan Africa, and Southeast Asia, better access to antibiotics could prevent millions of deaths.
• Innovation in drug development: The creation of new antibiotics targeting Gram-negative bacteria could save over 11 million lives globally by 2050.

Conclusion: A Call to Action

The findings from this study highlight the growing and evolving threat of antimicrobial resistance. Without prompt and coordinated efforts to prevent, manage, and treat infections caused by resistant bacteria, millions of lives will be at risk. Now is the time for governments, healthcare organizations, and researchers to intensify efforts to avert a global health catastrophe.