The Indian pharmaceutical sector saw a 200% surge in Foreign Direct Investment (FDI) in FY 2020-21.
The growing inclination of the Indian healthcare community towards foreign medicines and devices has been attracting large-scale investments from foreign pharma giants.
Due to the emergence of global medicine in India and high growth potential, foreign pharmaceutical companies are looking to register themselves in the country.
In this regard, management consultancy firms guide foreign investors through a hassle-free registration process.
Indian Market Entry Strategy
The first and foremost thing before entering the healthcare sector in India is market research.
If a foreign pharmaceutical company is looking to register itself in India, it is imperative to know about some important factors.
Management consultancy firms conduct thorough research on a foreign company’s behalf regarding their greenfield/brownfield investments.
Such firms use the “PESTEL” analysis method to know which plot is ideal to set up a manufacturing hub.
A PESTEL analysis is a strategy that is used to conduct research for determining the right business environment for a foreign company.
PESTEL is the acronym for Political, Economical, Social, Technical, Environmental, and Legal factors.
Management consultancy firms analyze these six factors to find the right business areas for companies.
- Political factors are those that are affected by the government, such as corporate taxation, free trade disputes, antitrust, and other anti-competition issues.
- Economic factors revolve around financial areas such as interest rates, employment rates, exchange rates, and inflation.
- Demographic situations, lifestyle, and consumer beliefs are social factors that impact commercial activity.
- Technical factors include automation, research and development (R&D), tech infra, and cyber security.
- Changes in the regulatory environment are known to be legal factors. These include industry regulations, operational licenses and permits, and intellectual property protection.
- Environmental factors can also have a profound impact on a company’s market risk and opportunities. Carbon footprint, climate change, and increase in extreme weather events are environmental factors that must be taken into consideration.
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Medical Registration Process for Pharma Companies in India
The Central Drugs Standard Control Organisation (CDSCO) of the Indian government is responsible for license approval of specific categories of drugs.
Before getting medicines and devices registered, foreign companies must ensure that they comply with all the regulations of the CDSCO.
Medical registration may seem like a lengthy procedure. However, management consultancy firms have reduced the complexity of the process.
While registering for a new drug, or a medical device, companies need to submit a list of necessary documents.
Documents Needed for Medical Device Registration
Once a pharmaceutical company hires a consultancy firm for getting medical devices registered, the firm will prepare a set of documents on the company’s behalf.
The documents required for medical device registration are:
- Power of attorney
- TR6 Challan
- Form 40
- Schedule D(I)
- Sale certificate
- Regulatory approvals
- CE certificate
- Conformity declaration
- PMS report
- Quality assurance certificate
- Master file of the device
- Master file of the plant
Categories of Medical Devices in India
There are four classes of medical devices in India based on risk offered to patients. The four classes are:
- Class A: Low-risk category of products like tongue depressors and thermometers.
- Class B: Moderate-risk products such as hypodermic needles and suction equipment.
- Class C: Moderate-high-risk products like lung ventilator and bone fixation.
- Class D: High-risk devices like heart valves and implantable devices.
Documents Needed For New Drug Application
The documents needed for getting approval for a new drug application are:
- Name of drug
- Form of dosage
- Composition of formulation
- Test specifications for Active ingredients & Inactive ingredients
- Pharmacological classification
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Medical registration in India can be a lengthy process. There are several compliances that must be met to obtain a valid license for medical devices and drugs.
In this regard, management consultancy firms can help foreign companies get valid medical licenses and set up manufacturing hubs by conducting thorough market analysis.
Tecnova is one of the leading healthcare consulting firms in India. It has over 35 years of experience in the field and a wide reach of approximately 21 offices in 15 markets globally. Such an extensive network chain and years of experience allow it to offer a personalized and effortless cross-border transaction for foreign organizations investing in India.