Regulation of pharmaceutical products and medical devicesMonitoring powers
What powers do the authorities have to monitor compliance with the rules on drugs and devices?
Section 22 of the Drugs and Cosmetics Act 1940 gives powers to the inspector to inspect any premises where drugs are manufactured, sold, stocked and distributed, where the investigating officer has reasons to believe that an offence under the act has been committed. The authorities can impose a ban on drugs that are likely to involve any risk to human beings and animals or that do not have any therapeutic justification. The authorities can impose penalties to regulate and restrict the manufacture of any drug that does not comply with the healthcare provisions.Investigation time frames
How long do investigations typically take from initiation to completion? How are investigations started?
There is no prescribed time duration for investigations and it mainly depends on the type of investigation. An investigation starts with the inspection of the premises wherein the drug is sold, manufactured, distributed, etc; the investigation officer takes samples of the drug from the said premises in the manner laid down in the Drugs and Cosmetics Act.Access to investigation materials
What rights or access does the subject of an investigation have to the government investigation files and materials?
Under Section 23 of the Drugs and Cosmetics Act, the inspector is bound to intimate the person he or she takes drugs from for sampling about the purpose of the same. Furthermore, Section 25 of the act provides that the drug analysts shall deliver a copy of the report to the person who is required to disclose their names under section 18A to the inspector for further investigation. With this, the inspector is prohibited from disclosing any information acquired during their official duties, except for purposes of official business or when required by a court or without a sanction in writing by his/her official superior under Rule 53 of the Drugs and Cosmetics Act.Investigations abroad
If pharmaceutical products or medical devices are made in a foreign country, may the authorities conduct investigations of the manufacturing processes in that other country?
No, the Drugs and Cosmetics Act does not give any such powers to the investigation authorities.Enforcement proceedings
Through what proceedings do agencies enforce the rules?
The drug inspector, under the powers given to him/her under section 22 of the Drug and Cosmetics Act, conducts the preliminary investigation. Once the inspector has prepared his/her report, he/she further institutes a prosecution before the Sessions Court for the same. Such proceedings fall under the Code of Criminal Procedure 1973. A special court can also be established for trial of offences relating to adulterated drugs or spurious drugs. Enforcement activities, such as imposing a ban on drugs and cosmetics, can also be undertaken by the agency itself.Sanctions
What sanctions and other measures can the authorities impose or seek in enforcement actions against drug and device manufacturers and their distributors?
Sections 26 to 32A of the Drugs and Cosmetics Act deal with all the measures that the central government, a court and the investigating authorities can impose or seek enforcement of. The central government can confiscate, regulate or restrict or prohibit the manufacture, sale or distribution of some drugs and impose a ban on certain drugs. The court can further impose penalties and sentence imprisonment for offences under the act.Actions against employees
Can the authorities pursue actions against employees as well as the company itself?
Under Section 34 of the of the Drugs and Cosmetics Act, the authorities can take action against the company and all the persons responsible for the conduct of the company’s business who had knowledge of the act, wherein a company has committed any offence under the act.Defences and appeals
What defences and appeals are available to drug and device company defendants in an enforcement action?
The defences would depend upon the nature of the offence. Defences include:
- having a valid and subsisting licence for the drug/device that is manufactured and the same is done in accordance with the provisions of the Drugs and Cosmetics Act and the Medical Devices Rules 2018; and
- having made all disclosures as per the requirement of the law.
The sanctions/orders of special courts can be appealable before the High Court. The orders of the Central Drugs Standard Control Organisation and the state authorities can be challenged before a court.Minimising exposure
What strategies should companies adopt to minimise their exposure to enforcement actions and reduce their liability once an enforcement action is under way?
A strategy that the companies can adopt to minimise their exposure in both cases is to have their drugs branded in accordance to the regulations of the Drugs and Cosmetics Act.
Companies can further reduce their liability by maintaining the records and furnishing information as and when required by any officer or authority for carrying out the functions under the act.
Companies must have independent teams to ensure regulatory as well as statutory compliance.Recent enforcement activities
What have the authorities focused on in their recent drugs and devices enforcement activity and what sanctions have been imposed?
The authorities under the Drug and Cosmetics Act are focused on maintaining the standards of quality of drugs in the market. The authorities have imposed bans on certain drugs and seized adulterated drugs. The authorities have also imposed heavy fines and penalties for non-compliance with the provisions of the act.Self-governing bodies
Are there self-governing bodies for the companies that sell pharmaceutical products and medical devices? How do those organisations police members’ conduct?
Self-governing bodies include:
- the Indian Drug Manufacturers’ Association, whose quality management and technical and regulatory affairs committee regulates the conduct of its members;
- the Bulk Drug Manufacturers Association of India;
- the Federation of Pharma Entrepreneurs;
- the Organisation of Pharmaceutical Producers of India;
- the Confederation of Indian Pharmaceutical Industry; and
- the Indian Pharmaceutical Association.
These self-governing organisations are advisory bodies and they function by sending representations, notices etc.