The pharmaceutical industry is heavily regulated and subject to stringent oversight because to the fact that it is a chemical-based, life-saving, and industry. It is mandatory and unavoidable for pharmaceutical companies to comply with the law. Pharma compliance standards are quite strict, and infractions of Indian Pharma regulations are taken very harshly.
Before we gained independence, India began its journey towards pharmaceutical production. The first pharmaceutical business to be established in India was Bengal Chemical and Pharmaceutical Works Limited, afterwards known as BCPL. The Indian pharmaceutical market size increased to over 1, 29,000 Crores in 2018 because to strong growth. Remarkably, nearly 20% of the world’s supply of pharmaceuticals comes from India. Moreover, the pharmaceutical industry makes up around 2% of India’s GDP and about 8% of its total merchandise trade, according to the Reserve Bank of India (RBI).
It can be said beyond a shadow of doubt that being in a pharmaceutical sector, it is mandatory to strictly comply with numerous statutory compliances. Let’s shed some light on the statutory compliances for pharmaceuticals firms in India enshrined under the different legislations.
What are the legal enactments applicable on Pharma Industry?
Pharmacy Act, 1948
It establishes guidelines for pharmacy education and practise in India. In the event of a proved crime, a registered pharmacist may lose his or her licence and be prosecuted.
Drugs and Cosmetics Act, 1940
The Act explains the laws and rules governing the production, marketing, distribution, and import of medicines, cosmetics, and particular medical devices. Additionally, this Act establishes the guidelines for the handling, distribution, and prescription of medications.
The Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954
Outlines regulations for drug advertising that discuss how to diagnose, treat, control, and prevent diseases and other conditions. It forbids the declaration of any drug having any “magical” therapeutic, restorative, or rehabilitative properties. This piece of legislation is applicable to a wide range of medical ailments and diseases.
Indian Patent Act, 1970
Keeps track of and controls new patents for pharmaceutical procedures and goods. An organisation or person’s name is typically used to register a patent for a 20-year period. The practise of “ever-greening,” in which the patent holder tries to extend the patent period by making small changes to the original patented formula, results in a sort of monopoly over a specific drug, is specifically prohibited by a special rule.
Drugs Price Control Order, 1995
This legislation oversees and regulates the cost of formulations and bulk medications. Additionally, this law specifies the profit margins at which pharmaceutical producers must sell their products to wholesalers and retailers in the Pharma sector.
Uniform Code for Pharmaceutical Marketing Practices 2014
It is a voluntary code of behaviour for pharmaceutical businesses, medical device companies, and equipment manufacturers. It was released by the Department of Pharmaceuticals. Doctors, pharmacists, and hospitals are specifically impacted by this Code. The prohibition of manufacturers giving gifts of any kind, including money, goods, vacations, etc., to anybody with the authority to prescribe or sell medications or drugs is one of the code’s most important provisions.
Trade Marks Act, 1999
It regulates the use of names, logos, and symbols for corporate branding and identification. An organisation or person with a registered trademark has the sole authority to produce and market goods under a certain brand name. It is unlawful and can result in legal action if someone else uses the name, logo, or symbol. A new entity is seen to be trying to “imitate” or “pass off” as the identity of the organisation that has been in operation for some time if it attempts to utilise a name or Trademark that has been used by an organisation or firm for many years without being registered.
What are the mandatory compliances for Pharma Companies?
The industry is faced with a variety of difficulties in the form of onerous general and sector-specific compliances that are applicable to various kinds of pharmaceutical enterprises. In India, compliances can be roughly categorised as one-time and continuing.
In four stages—setting up, pre-commissioning, post-commissioning, and post-production—a pharmaceutical firm is often subject to various one-time registrations and approvals.
Allotment of land, project-related approvals, construction approvals, labour, safety and health approvals, tax-related registrations, etc. approvals are included in this list. Then there are the continual compliances that the business must follow throughout the entire production process. They mix Central compliances with state-specific requirements.
The Drugs and Cosmetics Act of 1940 and its regulations, including the schedule on Good Manufacturing Practices and Requirements of Premises, Plant, and Equipment for Pharmaceutical Products, serve as the primary regulatory framework for the pharmaceutical business. Other significant industry-specific legislation includes the Essential Commodities Act of 1955, the Drugs (Price Control) Order of 2013, the Drugs and Magic Remedies (Objectionable Advertisements) Act of 1954, and the Drugs and Magic Remedies (Objectionable Advertisements) Rules of 1955.
The pharmaceutical industry often has the following sorts of compliance obligations: –
- Inspection-related Compliances
- Audit and Accounts
- Display Requirements
- Register and Records
- Employee Safety and Welfare
- Examination and Testing
To sum up, an effective pharmaceutical sector exists in India, producing reasonably priced medications both for the domestic market and for export. One of the industries with the highest regulation worldwide is the pharmaceutical and life sciences sector. Unsurprisingly, one of the biggest problems facing Pharma around the world is the difficulty of effectively managing complicated rules and regulations. The reputation of the company may be at risk, so these difficulties must be overcome. Now is the time for companies to adopt a 360-degree strategy for their compliance programmes, taking into account both internal ethical codes and compliance with regulatory obligations. Long-term competitive advantage in this cutthroat environment will go to a compliant pharmaceutical or life sciences company with a strong tone at the top.
Associate at Aggarwals & Associates, S.A.S. Nagar, Mohali