It is axiomatic that pharmaceuticals are essential for public healthcare, and hence their quality is of paramount importance, as any defect on the pharmaceuticals would cause adverse reactions on the patients, who consume them. There has been wide spread reports on availability of spurious / fake / counterfeit drugs in the country. Trade of spurious / counterfeit drugs are prevalent internationally and affects both developing and developed countries alike.
Despite Indian pharma industry posting a domestic turnover of more than Rs 34,000 crore and exports business of Rs 17,000 crore, the shadow of spurious drugs is likely to raise apprehensions about the availability of safe and efficacious drugs from India in general. The circulation of spurious drugs is of great concern to everybody, because of its adverse impact on human safety. The consumption of spurious drugs may result in a grievous injury and even death, due to the failure of intended pharmaceutical intervention.
What should the country do to tackle the spurious drugs? In India there are more than 5 lakh sales outlets / 12,000 manufacturing licenses, about 900-950 drugs inspectors and 605 districts. Only 17 states have drug testing facilities, of which only 6 laboratories have facilities for complete testing of all categories of drugs. In a scenario such as this, the problem cannot be effectively tackled in a routine manner through quality monitoring or licensing system.
Generally, spurious drug means the drug that does not contain active ingredients and counterfeit means an imitation of another product /brand.
There is no scientific data about the extent of spurious drugs in India. As per the government records it is less than 1 per cent. However, as per CII /IPA the extent of spurious drugs in the country is between 18 per cent and 20 per cent. But there is no scientific data to support the CII/IPA report. On the other hand, the data available from the government is based on the samples picked up by the drug inspectors for analysis. Hence, it also can't be considered as reliable data. But the fact is that spurious drugs are in circulation in India, mostly in the weakly administered drugs control organisations and rural areas. The central drugs standard control organisation's ambitious plan of extensive sampling throughout India may project a reasonable picture about the spurious drugs in Indian market.
According to Dr C M Kaneju, drugs controller, Delhi, out of 4,993 samples seized in Delhi in the past 3 years, a mere 61 found to be spurious and another 203 N.S.Q.
Major committees & recommendations
Hathi Committee - 1975
Task Force - 1982
Mashelkar Committee - 2003
Major recommendations of Task Force are:
● One inspector for every 100 medical stores (sales premises)
● One inspector for every 25 industries
● Well-equipped drug testing laboratories
● Intelligence wing
● Full time technically qualified drugs controller
Dr Mashelkar Committee, which was appointed by the Union Government on spurious drugs, submitted its report in 2003. It recommended that:
● The penalty for sale and manufacture of spurious drugs that causes grievous hurt of death should be enhanced from life imprisonment to death
● The offences related to spurious drugs should be made cognisable and non bailable
Besides, the committee also designated special courts for speedy trail of spurious drugs cases.
Dilemma of regulators
The truth is that regulators are facing a lot of challenges and problems in the country. Some of them include:
● Lack of adequate number of drugs inspectors / supporting staff
● Lack of facilities for speedy communication and mobility
● Lack of adequate funds
● Lack of adequate training in investigating skills
● Lack of uniformity in implementation /procedures
● Variation in law and order situation in states
● Lack of coordination between the industry and regulators
● Lack of protection to the regulators
● Enormous delay in court trials
● Lack of commitment from the state / central governments .
There are certainly ways to control the menace of spurious drugs. They are:
● Appointment of more number of inspectors / sub staff
● Promotions / incentives to the officers involved in the detection of spurious drugs
● Creation of intelligence / legal cells in all the states
● Sufficient financial resources
● Creation of special courts for speedy trail of drug cases / deterrent punishments.
● Accountability
● Facilities for speedy communication / mobility
● Adequate, well equipped testing laboratories / speedy analytical reports
● Interaction among industry / trade / consumer / medical professionals / regulators
● Making the offence cognisable / non-bailable / burden of proof on the accused
● Creation of better awareness among the consumers
● Drugs control authority at State / Central level headed by a technically qualified person
● Scrap loan licensing/ third party manufacturing - One manufacturer, one product manufacturing at one place.
● Periodical training / CEP to all the drugs control officer on the latest trends in the manufacturing and special phases on the detection, investigation and prosecutions
Various committees constituted by the Union Government from 1975-2003, including Dr Mashalkar Committee, have clearly stated that inadequate manpower and infrastructure of drugs control organisation both at central and state level have a great deal assisted the growth of spurious drugs in the country. According to the data submitted to the Supreme Court by the Union Government in 1992 in public interest litigation (PIL) No. 91/92 (Common Cause Society Vs. Union of India), the requirement of drug inspectors was 3000 against the available 703. According to the data presented before Dr Mashalkar Committee the requirement was 4,800 drug inspectors against 900-950 inspectors.
During the last 50 years, the Union Government and the State Governments have not taken any steps in the direction of strengthening the drugs control organisation and never bothered to recognise its role in health care system. The problem cannot be sorted out by appointing committees after committees or by forming the proposed central drug authority (CDA). The need of the hour is to strengthen the drugs control organisations at central as well as state levels.
Spurious drug is an evil for any civilised society, which needed to be tackled with topmost priority by involving all stakeholders and utilising all possible resources to make India a spurious drugs free nation.
(The author is the secretary general of All India Drugs Control Officer's Confederation)