According to the common usage, if a drug is manufactured by a person other than the original licensed manufacturer, it is regarded as “spurious drug“. Section 17b of the Drugs and Cosmetics Act 1940, defines a spurious drug as the one manufactured in the name of another drug or imitation of or substitute for or resembles another drug in a manner likely to deceive or manufactured by a fictitious or non existing individual or company, or substituted partially or fully by another drug or substance or if it purports to be a product of a manufacturer of whom it is not truly a product.
Some other kinds of drugs, though defined as misbranded drugs (Sec 17) or adulterated drugs (Sec 17A) are also referred to as “spurious drugs” by the public.
In addition to these three types of injurious drugs, there exists another kind of injurious drug viz, “not of standard quality drugs“, which are equally harmful. Since all these drugs are harmful and deleterious to the public health, it is an offence under the Drugs and Cosmetics Act 1940, either to manufacture or distribute them.
For these offences, the enactment prescribes punishments, varying in severity, including life term, according to the wickedness of the crimes. Since August 2009, certain offences related to spurious and adulterated drugs have been made cognizable and non bailable and punishments enhanced e.g., in Sec. 27(a), the 5 years term has been enhanced to 10 years. 10 thousand rupees fine has been increased to 10 lakhs or three times the value of the drugs seized, whichever is higher; in Sec. 27(b), the 1 to 3 years jail term and 5 thousand rupees fine has been raised to 3-5 years. Term and one lakh rupees or three times the value of the drugs etc. Likewise the punishments for repeated offences have also been enhanced. These measures definitely go a long way in deterring the culprits. The inclusion of a provision whereby the Courts can award the fine amount to the victims/their kin as compensation is a welcome amendment. Whatever may be the penalty or compensation, our priority should be to eradicate the menace of such injurious drugs.
Government analysts and the drugs inspectors appointed under the Drugs and Cosmetics Act are empowered to declare a drug as spurious/adulterated/misbranded or not of standard quality. The drugs control department is empowered to investigate such offences and to prosecute the offenders. Nevertheless the pharmacy professionals and the general public are also equally obliged to play their role in combating this menace. By these three pronged attack we can successfully eradicate harmful drugs and safe guard the public health.
First of all let us have a glimpse of the role of the drugs control department, which is one of the important factors among the three.
The primary works of the drugs control department are:
a) Licensing of the drugs manufacturing units, selling shops, drugs testing laboratories and blood banks.
b) Testing samples drawn by inspectors.
c) Prosecute the offenders.
d) Suggest amendments to the drugs rules.
In order to win the war against spurious drugs, the DCD should develop skill in the following areas also:
• Continuously watch the activity of black listed manufacturers and dealers.
• Prompt exchange of secret information among other State DCs.
• Shops, where the registered pharmacist is not seen , where bills are not issued, where purchase invoices are not promptly preserved, who get stocks from other states, propaganda agents and general item dealers should be regarded as potential sources and should be inspected frequently.
• Raid quacks and track the origin of drugs found with them
• Instead of indulging in letter correspondence with other agencies and State DCs, investigating officers should be deputed to collect necessary evidence personally, complete the investigation within 1-2 months and immediately file complaint in the Courts.
• Maintain cordial relationship with NGOs and other government departments like CDSCO, excise (State and Central) IB, revenue intelligence, police, H&FW, Ayush, commercial tax and customs etc.
• Capacity building programmes and compulsory training for the officers.
• Cultivation of informants and rewarding them.
• Developing quick testing facility.
• Watch sick units / closed manufacturing units whose licences are still not cancelled.
• Criminals are good innovators! They keep on changing the modus operandi and make use of the loopholes in the laws. Based on the field experience the DCD must keep on suggesting necessary amendments to the laws.
However, the following few amendments will go a long way in fighting the menace of spurious drugs.
a) Interstate sale / distribution of drugs should be restricted through a special class of dealers only, who should be termed as - the manufacturer's agent for the distribution thereof, under the meaning of Section 19(3).
As per the Sec .19(3), such agents are liable for prosecution just like the actual manufacturers of the injurious drugs, even though they have valid purchase invoices. Further, since they will be located within the state where the spurious drugs are traced, the State DCs can easily catch hold of them and prosecute quickly and effectively. They can easily monitor the movement of spurious drugs and can quickly and effectively recall the sold quantity. This situation definitely deters the wholesalers from getting spurious, misbranded, and adulterated or not of standard quality drugs, even under the cover of a sales Invoice.
b) Manufacturers and wholesalers can sell drugs directly to the medical practitioners. By misusing this loophole, clandestine manufacturers and wholesalers supply such drugs to rural doctors and also to quacks. The drugs inspectors hardly find time to visit them. Most of his work is at the retailers level. If the manufacturers and the wholesalers are prevented from selling directly to RMPs, they will have to buy drugs only from medical shops, which are frequently inspected. Further, the stocks are subjected to inspection at all the three levels thereby increasing the chances of detection of harmful drugs three folds. It is also a fact that the retail trade is least interested in making profit by selling harmful drugs, knowingly. They, being registered pharmacists, are dead against selling spurious drugs. This will go as a huge barricade against the proliferation of injurious drugs. This amendment has an indirect effect also as all the three stages of the suppliers get their share of profit.
c) Mushrooming of retail shops by non pharmacist capitalists may also encourage illegal activity, due to depletion of the margin of profit. There is ample powers granted to the Licensing Authority under the Drugs and Cosmetics Rules to restrict the mushrooming of retail shops [Rule 62B(2) and 64(2)]. Unfortunately, nobody enforces it for the fear of being challenged in the Courts. If only these rules are re-framed to be more precise by defining the method of determining the maximum number of medical shops to be permitted and the basis on which new licences to be granted in a given area, the Licensing Authorities simply love to enforce them.
d) Another major hurdle in curbing the distribution of injurious drug is the long time taken to issue test reports and the unjustifiable delay in completing investigation and sometimes the unwarranted delay in giving administrative sanction to file a prosecution case. The time taken to issue test reports by the lower or appellate laboratories may extend to some years or even up to the expiry date of the drug itself! The IO may keep the investigation pending till his transfer! Controlling Authority may sit on the file without giving permission to file complaint, till his retirement! To avoid such situations, time limit has to be fixed for the following activities by amending the rules:
e) i} for submitting sample to the laboratory for testing – one day.
ii) to issue the test report by the laboratory – one to fifteen days.
iii) to complete investigation and to seek sanction for prosecution – two weeks.
iv) for giving sanction – one day.
v) for filing charge sheet the Court – two days.
In addition to this, provision to punish officers who breach this time table without tenable excuse, should also be made punishable.
If such amendments are brought in we can definitely bring the spurious drugs culprits to books effectively and quickly.
Another useful amendment is the revision of the minimum number of registered pharmacists to be employed in retail shops. At least two registered pharmacists may be made mandatory as the retail shops work for more than 12 hrs in a day. In addition, the proprietor or at least one of the partners should compulsorily be a registered pharmacist.
Now we shall see the role of the pharmacy professionals in this task. According to me, they are the most important group as they can easily identify a spurious drug.
• They should refrain from selling drugs to the quacks and on their prescriptions. On the other hand, ,they should provide secret information about such quacks ,to the law enforcing departments like DHO, Ayush, DCD, Police etc.
• Retailers should not buy stocks from such dealers who refuse to issue invoice or issue only for a partial quantity or issue only after exhausting the stocks etc. Such practices should be reported to the DCD immediately.
• They should confidentially notify the DCD, any changes observed in the color, shape, size etc, of the label or packs of the drugs, immediately.
• Black listed dealers should be avoided. New suppliers should be screened thoroughly. Local and trustworthy dealers should be preferred to interstate suppliers.
• Wholesalers, who offer long sight/credit facilities or free goods, should be carefully dealt with.
• We should always be abiding by the professional oath and ethics.
Finally we shall see the role of the general public in combating this problem.
*Avoid consulting quacks as they are the significant spreaders of injurious drugs. On the other hand, quackery should be brought to the notice of the law enforcing departments.
*Should never indulge in self medication. Buying drugs without a prescription creates on opportunity to dishonest sellers, to pass on injurious drugs to the gullible patients.
* Make sure that the Registered pharmacist supervises the sale and signs the bill. (His photo and specimen signatures are available there)
*Make sure that the drug name and other details recorded on the labels should tally with the prescription and the cash bill.
* It is desirable to show the drugs bought to the prescriber, before taking.
*In case of any doubt, or if the desired cure is not obtained or if any undesirable action is produced, the prescriber should be consulted immediately. A complaint has to be registered in the DCD secretly, without informing the dealer, to avoid the destruction of the evidence. In most cases, the customer himself takes the seller to task and after a great showdown, approaches the Authorities to complain against that dealer but not against the drug! This is detrimental to the investigation.
* The empty containers and the left over and date expired drugs should be destroyed.
*Under Section 26 of the D&C Act, a purchaser is enabled to get the sample analyzed in govt laboratory and to receive a test report signed by the govt analyst. This report is a conclusive evidence, admissible in Courts under Section 25(3).
Thus, a common man can get doubtful drugs tested in legal laboratories and if the drug is declared as not of standard quality, adulterated, spurious or misbranded by the govt analyst, he can file criminal case against the accused, by himself.
• Under Section 32(1) (c), an aggrieved person by himself and under Section 32(1) (d), any recognized consumer association, (even if such aggrieved person is NOT its member) can file a criminal case against the vendors and the manufacturers, even though such manufacturers are situated in far off places. The Magistrate is empowered to implead the manufacturers. The public must exercise this right granted to them under these Sections, instead of waiting for the agencies to take action. This will prove to be the greatest weapon against the proliferation of injurious drugs.
In all, with the hard work and intelligence of the DCD, the pharmacists adhering to his professional ethics and the consumers exercising their rights, the menace of injurious drugs can be overcome.
(The author is Rtd. Drugs Controller for the State of Karnataka).