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A strong, proactive drugs control authority, establishment of an independent intelligence branch at state level, appointment of officers in the intelligence branch having aptitude for investigation, effective networking between stakeholders along with the incorporation of Radio Frequency Identification (RFID) tags on drug packs are some key measures put forth by pharmaceutical experts to control and to curb the menace of counterfeit drugs in the country.
Various provisions in the Drugs & Cosmetics Act call to restrict the circulation of spurious, misbranded, adulterated and substandard drugs which come under the category of counterfeit drugs, stated Atul Nasa, vice-president, All India Drugs Control Officers Confederation (AIDCOC).
While ‘counterfeit medicine’ is not defined under the Drugs and Cosmetics Act, 1940, ‘spurious drug’, ‘misbranded drug’, ‘adulterated drug’ and ‘not of standard quality drug’ are outlined separately. However, the three definitions together cover instances of counterfeiting incorporated under WHO definition. Therefore, there is a need to look into the current regulations and adopt a strategy to curb the menace, he added.
Concurring with Nasa, RA Gupta, vice-resident, Indian Hospital Pharmacists’ Association said that strong regulatory framework and stringent enforcement of the provisions of Drugs and Cosmetics Act is the first requirement along with presence of qualified pharmacists in all retail/wholesale pharmacy outlets. Presence of adequate number of drug testing laboratories and qualified drug inspectors to ensure that the suspected samples are tested expeditiously and use of modern technology tools like bar code, holograms and RFID are some of the other suggested tangible solutions.
Gupta added that maintenance of records related to purchases and close scrutiny of chemist-stockiest & manufacturer would ensure the reliable sources of drug supply. It would also caution the pharmacy outlets to refrain from selling sub-standard, adulterated or spurious drugs.
In addition, Hospital Pharmacists should be involved in drug procurement process of its institution. Tenders below the actual cost of finished product (drug) should be rejected, so that genuine companies may be attracted for the supply in government institutions, he pointed out.
Policy-makers and enforcement authorities need to take lead and prioritize the fight against counterfeiting of medicines. Pharmacy Council of India ought to prepare a ‘Central Register’ of pharmacists. New licenses for chemist outlets need to be issued only to registered pharmacists. Pre & Post Purchase sampling should be ascertained. Fast track courts should be established up to district level for speedy action.
There is also need for a massive public awareness campaign by government agencies to ensure quality drug supply and sale. However, in order to ensure fool-proof remedy for spurious drug circulation, pharma industry should adopt RFID bar code for drug package and nano particles incorporation in the package or pill to prevent fraud, stated Dr N R Rau, Professor of Medicine, KMC, Manipal University.
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