The deficiencies/defects could be any of the following and may arise due to faulty manufacturing process, poor quality control system or faulty storage conditions, or criminal activities of unscrupulous traders selling fake/spurious/adulterated drugs.
i. Deficiency in the active ingredients
ii. Drug delivery inside the body may be slow or defective
iii. Impurities in the drug leading to toxic effects
iv. Fungal growth such as in IV fluids
v. Spurious drugs
vi. Adulterated drugs
vii. Fake drugs
viii.Potency deteriorated due to faulty storage.
2. Misbranded Drugs (Chapter III of Drugs and Cosmetics act 1940):
Sections 9 and 17 of the Act clarify that a drug shall be deemed to be misbranded:
i. If it is so colored, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is
ii. If it is not labeled in the prescribed manner
iii. If its label or container or anything accompanying the drug bears any statement, design or device which any way makes any false or misleading claim for the drug.
3. Adulterated Drugs (Chapter III, The Drugs and Cosmetics act, 1940):
As per Section 9A and 17A of the Act, a drug shall be deemed to be adulterated:
i. If it consists of any filthy, putrid or decomposed substance
ii. If it has been prepared /packed / stored under insanitary conditions contaminating it with filth or rendering it injurious to health
iii. If its container is composed of any poisonous or deleterious substance which may render the contents injurious to health
iv. If it bears or contains a color other than that prescribed or if it contains any harmful or toxic substance rendering it injurious to health
v. If any substance has been mixed therewith so as to reduce its quality or strength.
4. Spurious Drugs (Chapter III of The Drugs and Cosmetics act, 1940):
As per Section 9B and 17B of the Act, a drug shall be deemed to be spurious if:
i. It is imported/manufactured under a name which belongs to another drug
ii. It is an imitation of/substitutes for or resembles another drug or bears upon its label or container the name of another drug so as to hide its true character and cause deception
iii. The label or container bears the name of a fictitious individual or company purporting to be the manufacturer of the drug
iv. It has been substituted wholly or in part by another drug or substance
v. It purports to be the product of a manufacturer of whom it is not truly a product.
5. Adverse Effects of Poor Quality Drugs on the Patient:
Poor quality drug may affect the patient adversely in many ways:
i. By denying the actual intended medicine in the intended dosage
ii. By consumption of undesirable/toxic ingredients, leading to toxicity
iii. By infections such as fungal growth and serious complications, even deaths
iv. By deterioration of the active ingredients leading to harmful effects
v. Allergic reactions, anaphylactic shock.
6. Ensuring High Quality of Medical Supplies:
It is the responsibility of the management to ensure provision of right quality drugs in the right condition and at the right time by implementing the following measures:
1. Purchase of drugs only from the reputed manufacturers with reputation for adherence to the quality standards.
2. Purchasing the drugs from dealers/suppliers who have the system of proper storage under controlled conditions. It is better to make a visit and actually see the storage conditions on ground before placing the orders.
3. Procuring and stocking just the right quantities, enough to meet the requirements to avoid stock outs. Overstocking too must be avoided as it not only blocks large amounts of money but there is also the danger of deterioration or expiry of shelf life.
4. Ensuring that the drugs purchased have minimum 80% residual shelf life.
5. Implementing a laid down procedure for receiving, inspecting, taking on charge, well known to all the staff.
6. Making it mandatory that all the medical store supplies will be taken on stock only after the inspection of quality of the entire stock received, by a standing committee of officers which should include the chief pharmacist and a member of the Drugs and Therapeutics Committee.
7. The standing committee will check the following aspects in detail:
i. The condition of the packages as well as the drugs inside
ii. The date of manufacture and expiry so as to be sure that the items have at least 80% residual shelf life
iii. The genuineness of the drugs received. In view of the large scale supply of fake medicines, it is extremely important.
8. Getting random samples tested by the drug laboratories:
9. Punishments: Under the Drugs and Cosmetics Act, 1940. Manufacture/sale and distribution of spurious/adulterated/misbranded drug is an offence punishable with imprisonment for 5 years and a fine not less than 10 thousand rupees.
In addition, the offender’s name, place of residence, the offence committed and the punishment awarded, has to be published in the news papers at the expense of the convicted person.
Knowingly and intentionally selling an adulterated drug or selling a drug or medicinal preparation as a different drug or preparation are offences under IPC sections 275 and 276 punishable with imprisonment up to six months (Life imprisonment in UP and WB).
7. Safe Storage of Drugs:
Storage of drugs should be such as to:
i. Prevent deterioration of potency of drug due to adverse effect of the environment
ii. Prevent accidental mixing up/reaction between the items
iii. Promote compliance with the “First in, First out” policy
iv. Prevent pilferage, misuse, abuse of the drugs such as narcotic drugs
v. Minimize the chances of issue of incorrect drug due to any mix up.