COMPLIANCE SPECIALIST: DRUG AND COSMETIC LAW

The Drugs and Cosmetic Act, 1940 is an Act of the Parliament of India that regulates the manufacturing, importing, and distribution of such drugs and cosmetics that are safe, effective, and conform to India's standard quality.

Meaning of Drugs and Cosmetics

'Cosmetic' refers according to the Act (interpretation)

To any article used to rub, sprinkled, sprayed on or introduced to beautify the human body or any part thereof used to cleanse, beautify, promote attractiveness or alter the appearance of any article intended for the use of cosmetics. However, this excludes soaps.

Likewise, "Drug" refers to as interpretation

1. To all medicines for internal or external use of human beings or animals and all substances which are intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including but not limited to preparations applied on the human body to repel insects like mosquitoes.

2. Such substance (other than food) intended to affect the structure or any other function of the human body or intended to destroy vermin or insects that cause disease in human beings or animals.

3. All the substances intended for use as components of a drug including empty gelatin capsule and,

4. Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals.

Drug and Cosmetic law is one such branch wherein; a lawyer can take up this profile being a Compliance Specialist. There is a growing need for skilled compliance specialists in cosmetics, drugs and food regulations. Their job is to perform critical tasks in order to interpret and adjunct the laws in compliance with the standards laid down by the government.

Objectives of Drug and Cosmetic Act, 1940

1. Manufacture, distribution and sale of drugs and cosmetics by qualified persons only.
2. Regulate the import, manufacture, distribution and sale of drugs and cosmetics only through licensing.
3. To prevent substandard of medications in order to maintain high standards of medical treatments.

Responsibilities of a Compliance Specialist

1. Compliance specialists, also known as compliance officers, ensure that organizations dealing into drugs and cosmetics are updated with the regulatory framework guided by the government in accordance with the company state and federal regulations.

1. To develop, implement and enforce policies and procedures that keep companies products and physical sites working in an ethical manner.

1. In case of violations of the guidelines, it the responsibility of the lawyer to conduct audits or investigations and recommend areas and scope for improvement. They are responsible for taking corrective actions and for maintaining future compliance.

1. Compliance professionals are often an organization's "one-stop-shop" for employees who want to obtain appropriate regulatory documentation, receive training, or confidentially report compliance concerns.

Skills to be honed for a Compliance Specialised

1. Critical Reasoning – you need to be able to interpret complex problems and making decisions that can have an adverse effect on the organization. Thinking logically and analytically is the key to this career.

1. Emotional Intelligence – or referred to as People Skills. This is a career option wherein you will have to come in close contact with people daily, and being polite, possess self-awareness, even-keeled is essential.

1. Research – regulations are complex, and lawyers are expected to get the right interpretation of it and implement it rightly. Therefore, it is essential to have research skills to be able to find the best reliable solution.

Pay Scale

According to PayScale, the current national average for a mid-career compliance manager is $80,000. Salaries can vary, however, from $52,000 to more than $125,000, depending on an individual's skill, years of experience and job location.

Conclusion

Even though Compliance Specialist in Regulatory Affairs is one of the most exciting and rewarding careers, but still one has to consider that it has its own challenges. So there are a lot of things to be considered when you think of Compliance Specialist in Drug and Cosmetic Law as a Career. You need to evaluate the goals both personally as well as professionally in order to have a better understanding of how our career can meet your goals.