Pharmabiz
 

DEFINE SUBSTANDARD DRUGS

Ramesh ShankarWednesday, June 2, 2021, 08:00 Hrs  [IST]

In its first serious attempt to wipe out spurious drugs from the pharmaceutical market and redeem the image of Indian pharma industry, the Central government way back in 2008 had brought the Drugs and Cosmetics (Amendment) Bill, stipulating stricter penalties, including hefty fine and non-bailable arrest, for manufacturing and marketing of spurious drugs. By enacting such a law, the Indian government wanted to allay the apprehensions of the international community that India is home to huge quantity of fake drugs. In fact, there were 'incorrect' reports, especially in the international media, which suggested huge presence of spurious and fake drugs in India. No doubt, controlling spurious drugs is a herculean task as these products have already entered the healthcare systems of almost all the countries in the world. As usual, developed nations like the US and the EU put the blame for this menace on developing nations, especially India and China for exporting this problem to the western world. Everyone knows that this is more of a biased and an exaggerated allegation with no reliable data to support. But all said and done, the fact remains that both these countries do contribute, up to an extent, to this global menace. By making the amendment in the law, the Indian govt wanted to drive home the message to the world that the country recognized the reality.
But, the law was enacted without taking into account the industry’s concerns, especially the small and medium enterprises, over lack of safeguards for legitimate manufacturers as there was one major lacuna in the Bill - lack of definition on substandard drugs. The SMEs were apprehensive that since there is no separate definition on substandard drug in the law, if any drug is found substandard the manufacturer will be charged for manufacturing and selling of adulterated or spurious drugs. Since this is a non-bailable offence, the manufacturer will be arrested and by the time he proves his innocence it will be months, or even years. Though the industry has since been knocking at the doors of regulators to issue a guideline to define substandard drugs, it fell on the deaf ears of the regulators. As the issue lingered on, recently the Small and Medium Pharma Manufacturers Association wrote a letter to DCGI Dr V. G. Somani asking him to issue a directive to state drug controllers to take action on samples of drugs declared spurious or not of standard quality (NSQ) as per Drugs Consultative Committee's guidelines. The association urged DCGI to incorporate specific definition of NSQ drugs in Drugs and Cosmetics Act, 1940 based on DCC guidelines. This will enable to prevent misinterpretation of NSQ drugs as spurious and adulterated drugs and subsequently stop the prosecution of licensed manufacturers whose drugs have been declared NSQ. Standards of drugs are prescribed under Section 16 read with second Schedule and Rule 124 to 126A. But the problem is the term NSQ is not defined. Due to this, NSQ drugs are very often classified as adulterated or spurious drugs. As a result, genuine manufacturer, who is not involved in manufacture of spurious or adulterated drugs, is exposed to harsh penalties and restrictions on bail. It is a fact that manufacturers are not always responsible for NSQ drugs. Improper methods of analysis or human error during analysis are also responsible for it. At times, drugs despite having required quantity of active ingredients lose potency due to improper storage and stability issues. There is definitely merit in the industry’s concerns as no genuine manufacturer should be punished for lack of clarity on a term in the law. The drug authorities should understand the genuine concerns of the industry and take some corrective measures to safeguard the innocent drug manufacturers.

 
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