Government vs Drug regulation violators : Strict monitoring needed

- Archana Ajith

With failing quality of drugs, the Health Ministry is planning to make companies, which market and promote the sale of drugs, responsible for any violation of drugs regulation by the manufacturers.

As per a recent proposal by the ministry, marketers of the companywill be penalized and may face imprisonment for
Substandard drugs, or life imprisonment in case the medicines are found specious, said a senior health ministry official.

With a sudden rise in the degrading health conditions of India led to the formulation of this proposal.
The Drug Technical Advisory Board, which is India’s highest drug advisory body, approved the concerned proposal said the official.

Presently, if a violation occurs the manufactures are held responsible and not the marketers.

Nowadays, big Pharmaceutical companies market medicines that are manufactured by small companies with a cheaper rate structure, making room for the market players to promote the sale of spurious medicines and paving a way for ailing conditions in India. Mostly the medicines prescribed by the doctors for cold or a cough or even headache are either fake or of poor quality.

Nowadays, due to the lack of finances people are not hesitant to buy medicines of low prices. The sale of adulterated medicines is marginally less in price, which is the reason the manufacturers are making the drugs in exceedingly low quality.

According to a statement by an official, The Drugs and cosmetics Act will have to be amended to make pharmaceutical marketing firms liable for the violation of any law and simultaneously the legal actions will be taken against both the manufacturer and the marketing company.
As per the proposal, the companies marketing the medicines shall be penalized in case of any violation. This includes, minimum imprisonment for 10 years for drugs not of standard quality or life term—and a minimum fine of Rs10 lakh or three times the value of the drugs confiscated, whichever is higher. And it makes the offence non-bail able in some cases.

The official said, the drug regulator of Central Drug standard Control Organisation (CDSCO) will decide if the medicines are substandard or of low quality.
The aim is to ensure that the quality of drugs is not compromised and also to avoid the consequences that come along with the use of adulterated drugs, said the official.

The proposition further raises a few questions regarding the authenticity of the drug regulator and how they shall collectively be the deciding factor on the quality of drugs?
The issue of adulterated medicine has been pertaining since years now and yet none cold stop the production. Why wasn’t there any inspection of small manufacturing firms done when the production of such fake medicines was loud in the market?
Medicines for diabetes are high-priced and people from rural areas are not aware of the sale of such medicines. They end up buying what seems to be light on their pocket and risk their lives. On the other hand, such purchases led to the growth of such illicit activities.

However, there are also concerns that the new Act gives too much power to the drug inspectors at the state level. Still, it does lay down guidelines for the state drug control organizations, clearly stating standard operating procedures to examine and process various violations of the law.
Once the procedures are dotted, the nature of such activities can be easily controlled. The offence is biggish if we draw the facts and examine the harm it has caused to the health system of India.
The law should bring up a difference if not a change, because if the ministry fails to tackle the situation, the country and it’s high held policies stand in question and not the segregated bona fide small-scale manufacturers.
The regulation is under the control of drug regulators, but who regulates such regulators? Every state has hundreds of licensed pharmacy running under it, and the drug regulators operating in those regions are less in comparison to the number of pharmacy. And such officials usually defy the law and evade from their duties that sabotage the main motive behind the formation of a law. A law is as good as its implementation, if the officials fail at their part, the loss can never be restored. But if the ministry set up an abiding body to regulate the activities of the drug regulators, and avoid any slacking by them, they can easily carry forward the proposed law. The body should be powerful enough to refrain the regulators or the drug manufacturers from any fallacious activity.
If the matters advised are withheld properly the executed law shall preclude the sale of adulterated drugs.

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