Drug Regulations in India – Explained, pointwise

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An adulterated cough syrup of a private firm, Digital Vision, has caused the death of 13 children in 2020. Publicly available data (RTI) shows that Seven Indian state regulators, including that of Maharashtra, Gujarat, and Kerala, have found drugs from the company to be substandard at least 19 times since the formation of the firm in 2009.

The only punishment the regulator meted out in most cases was the suspension of the firm’s license temporarily for a few days. During the inspections, the regulators also found out that the company has fabricated records, hadn’t maintained basic paper records, and have also procured raw materials for its cough syrup from an unlicensed dealer, etc. 

Despite that, the State drug regulators took the firm to court to push for imprisonment and penalties only for four out of the 19 times. Even now, the firm continues to manufacture its full complement of drugs, except cough syrup. This highlights the issue of selling substandard drugs and Drug regulation in India.

How are drugs regulated in India? 

The Drug and Cosmetics Act, 1940 establishes regulatory control over the import, manufacture, distribution, and sale of drugs and cosmetics in India. The Act makes the sale of substandard drugs as a serious offence, as these drugs are capable of bringing harm to patients. Under this Act, a jail sentence or fine can be imposed. 

This also established the Central Drugs Standard Control Organization (CDSCO) for discharging functions assigned under the Drugs and Cosmetics Act. The State Health department has to regulate the manufacturing, sales, and distribution of drugs. Drug Inspectors control the implementation at ground level.

Further, if the drugs are found to be substandard, then the drugs can be recalled from the market and the manufacturer had to conduct a root cause analysis for the faulted reason. 

The Drugs and Cosmetics Act also has provisions to compensate the families of victims of adulteration. It calls for the penalty to be extracted from a convicted manufacturer and given to families of the victims. 

Read more: Medical devices now under Drugs and Cosmetics Act
When the medicine is considered substandard, adulterated, and spurious? 

Substandard: It is considered substandard when it doesn’t have what is mentioned on the box. It could be one of several things like the medicine has less than 90-95% of the amount of active ingredient claimed on the label; contains impurities apart from the active ingredient, excipient listed on the label, etc.  

Adulterated: It is the one that contains a poison or other noxious matter. 

Spurious: A spurious drug is one that masquerades as another genuine drug. It is a drug with no active ingredient in it. 

What are the challenges associated with Indian drug regulations? 

Non-scientific classification of offence: The distinction between minor and major offenses isn’t scientific in India. States do not prosecute dissolution, disintegration, or impurity failures because they deem them minor offense. 

A drug with an active ingredient less than the mandated 90-95% can, in fact, be as dangerous as a drug with an active ingredient less than 30%. For example, if an emergency drug doesn’t disintegrate in time, it will not save a person’s life. It is not a minor offence. 

Liberal punishmentsDrugs Consultative Committee, an advisory body to state regulators, issued guidelines in 1993 and then in 2010. These guidelines argue that prosecuting every case of substandard drugs would lead to the harassment of manufacturers. So, the committee called to prosecute the manufacturers judiciously.

Protect the pharma industry, not the victim: India’s hot and humid climate and weak drug distribution infrastructure might lead to substandard drugs. So, to protect the emerging pharma industries, the state drug regulators initially take only administrative action—such as a temporary suspension of the license for an offence. If the company still commits an offence, then only the regulators prosecute the firm. For instance, only 4 out of the 19 offences resulted in prosecution for firms like Digital vision.  

Competition between states to boost the Pharma sector: There is a competition between states to outbid each other. This means they are not bothered about the quality of the products being sold in the country.  

They issue manufacturing licences to all and sundry without looking into whether Good Manufacturing Practices and other requirements are being followed. 

Interstate variation in the prosecution: There are variations in prosecuting the manufacturers for the substandard drugs. For instance, the Kerala regulator will prosecute any case in which the active ingredient falls below 70%. Maharashtra will prosecute if the active ingredient is less than 30% of the labeled amount. On the other hand, Gujarat will only prosecute spurious or adulterated drugs. This results in interstate variation in the standard of drugs as well. 

Systemic challenges in Drug regulation: Indian State and Drug Regulators often have to deal with problems like poor training, antiquated record-keeping systems, understaffing, and pressure from the pharmaceutical industry, etc. This led them ill-equipped to enforce recalls and root cause analysis. For example, Himachal Pradesh requires at least 47 drug inspectors to oversee sales outlets and manufacturing units. But the entire state has only 26 inspectors.  

How to improve drug regulations in India? 

Amend the Drugs and Cosmetics Act: The primary goal of the Drugs and Cosmetics Act is not to respond to substandard drugs retrospectively, but to prevent them altogether. So, the DCA has to be amended to prevent the manufacturing of substandard drugs in the first place.  

The Union government has already constituted a committee for framing legislation regarding new drugs, cosmetics, and medical devices. This committee has to include necessary amendments to prevent the manufacturing of substandard drugs.

Read more: Panel set up to draft Bill on drugs, cosmetics and medical devices

Adopt Good Manufacturing Practices: Manufacturers should adopt a strict quality control system. There is a need to follow simple checks and balances, such as testing a raw material before putting it into a drug, buying raw material from a licensed manufacturer, and maintaining clean equipment, etc. A root cause analysis should be done quickly in case of any quality failure. 

Coordination and uniformity between various departments: Every state follows different standards to regulate the cases. Also, there is no/ very less coordination between different state regulators. A mechanism should be built, where regulators should have proper communication links between them. Also, a set of uniform standards should be followed. 

Address the systemic issues in Drug regulation: There is a need to provide adequate training to the staff. Also, the vacancies should be filled immediately so that they are not overburdened.

The sale of substandard drugs in India has to be stopped not only because it is illegal but because it is creating life-threatening situations.

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