how to become a pharmaceutical lawyer in india

What is the qualification required to become a lawyer in India?

1 Choose a suitable law course that you want to study. As mentioned before, LL.B. (from an Institute recognized by the Bar Council of India) is the minimum qualification required to become a Lawyer in India. There are two ways available to pursue this course- Integrated law course and Bachelor of Law (LL.B.).

How to start a pharma company in India?

Jul 09, 2020 · There are crores of children in India, who want to study to become doctor, IAS, IPS, actor or lawyer, which is also known as Advocate. But to become a lawyer requires a lot of hard work and studies. And advocacy for this also has to be learned.

How do I get a drug license in India?

Our lawyers have deep insights on key industry trends and risks. We advise local and multinational clients in several critical and strategic areas. As a full-service law firm, we are able to help clients navigate through the complex regulatory environment and offer robust legal and commercial solutions aligned with business objectives.

What are the rules and regulations of drug manufacturing in India?

By 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and sixth largest market globally in absolute size. However, the market is predominantly a generic one and therefore the laws and regulations of the country, including intellectual property, drug regulatory, drug pricing, prescriptions, etc., are ...

How to start a company?

Starting up a company is exhausting when it comes to costs and expenditures. Try to save money as far as possible. Cut in costs like overhead costs like furnishing, buying a commodity etc. Expense should be focused on essential parts like documentation, premises, products manufacturing etc.

How to start a company with hypothesis?

You can do it by knowing about its demand, competition and accessibility of resources in the location you are targeting. Define your company goals and be creative about the services.

What is the first step towards materializing things?

Consulting a drug inspector for a license should be the first step towards materializing things. Here are the documents and license that are necessary for a pharma company to have: Drug License No. (D.L.) Number. GST or Goods and Service Tax Registration.

Is a sole proprietorship a good idea?

A sole proprietorship is a good way to have all the profits but the partnership has its own benefits. If you think the partnership is good then go for contracts to avoids losses like com faced. Make assumptions on each point after the conclusion of things like investment, expenditure, costing etc.

Can you opt for pharma manufacturing?

One can opt for pharma manufacturing for procurement of drugs and pharma products. You can contact a pharma manufacturing company. Look for companies which have loan facilities or only 50 percent payment in the first half of final deal. This will lighten the burden of paying manufacturing cost at first.

How long does it take to become a lawyer in India?

It can be pursued only after completing graduation (3 or 4 years long course) from a recognized University/Institute. Course duration is 3 years. After completing any one of the above mentioned law course, graduates may enroll with relevant Bar Council and start law practice in India.

What is the minimum qualification required to become a lawyer in India?

Bachelor of Law (LL.B.) from an institute recognized by the Bar Council of India is the minimum qualification required to become (or practice as a ) Lawyer in India. LL.B. course can be pursued in two different ways-

How to secure admission in reputed law institute?

To secure admission in a reputed law institute, one must score valid marks in relevant entrance tests. Entrance tests have to be cracked in both cases- integrated law course and LL.B.- to secure admission. CLAT (Common Law Admission Test) is a well known law entrance test.

What is a lawyer?

A lawyer is a person who practices law. A lawyer is a professional who has knowledge of the law and legal procedures. Job profiles available in front of a lawyer include barrister, attorney, solicitor or chartered legal executive. Depending upon the job profile, a lawyer may represent his/her clients at court, provide legal assistance ...

What is CLAT test?

CLAT (Common Law Admission Test) is a well known law entrance test. Other than CLAT, there also exist state-wise and institute-wise law entrance tests. AILET, LSAT, AMU Law Entrance test, DU Law Entrance test etc are some of the well known entrance tests.

What is the entrance exam for law school?

The entrance exam is called the Common Law Admission Test , which is quite popular.

How long is the LLB exam?

After clearing this exam, you will get admission in law college directly. LLB is a 5 years course. Before that, in the entrance exam, you will be asked questions about legal reasoning, mathematics, and general awareness.

What is the full form of LLB?

If you do not know about LLB, I would like to tell you that the full form of LLB is Legum Baccalaureus or Bachelor of Legislative in English. Apart from this LLB is also known as Bachelor of Laws, which is an undergraduate course in India, which can be completed after 12th.

What happens after you complete an internship?

Finally, after completing the internship, you will have to enroll in your State Bar Council. After this, you have to clear the All India Bar Examination, which is organized by the Bar Council of India. After clearing this exam, you will get a certificate.

What are the healthcare imperatives in India?

The healthcare imperatives and the resultant laws and regulations around health in India are unique. In the absence of any significant reimbursement or insurance system in place, the focus of successive Indian governments has been on achieving significant reductions in out-of- pocket expenditure on healthcare and drugs. Drug prices and affordable healthcare have been an integral part of campaign rhetoric in general and state elections since 2014. The issue of affordable healthcare and the disproportionate focus on prices of drugs and devices have been occupying a progressively larger space in the political and media arena. Since 2014, the current government has not only increased the scope of price control of drugs and devices that have been notified as drugs (stents, orthopaedic knee implants) but is now proposing significant legal and regulatory changes. The establishment of public pharmacies dispensing generics and the policy and regulatory measures discussed below are part of a push to make India an overwhelmingly generic-generic market.

How many medical devices are there in India?

Currently, there are 22 medical devices in India that are notified as drugs, out of which four are already under price controls and the rest (18) are on NPPA’s radar to be put under price control as well. The draft National Pharmaceutical Policy 2017 (draft NPP) talks of expanding the scope of price controls.

What is the MDR in India?

The Government is simultaneously in a process of streamlining the medical device industry, which has seen a paradigm shift this year with notification of separate and distinct Medical Devices Rules, 2017 11 (MDR) effective from January 2018. The MDR has been notified with an aim to bring within its purview the entire universe of devices by notifying them as “drugs” (as defined in the DCA) in a phase-wise manner thereby bringing them within the jurisdiction of CDSCO, the drug regulator. Currently, only 22 types of medical devices are regulated in India as “drugs” under Section 3 (b) (iv) of the DCA and all other non-notified medical devices do not require any registration certificate or other regulatory approvals. With the MDR and the subsequent notification of medical devices, regulatory approvals would be required. CDSCO has already circulated a draft list of 462 medical devices and 250 in vitro diagnostics (IVDs) along with their risk classification to encourage importers, manufacturers, distributors, and supply chain personnel to voluntarily adhere with the safety, performance, and quality aspects as stated in the MDR for creating the proper ecosystem for its effective implementation. 12 Further, deliberations are underway for developing a detailed guidance on essential principles for safety and performance to be followed in the manufacturing process of medical devices intended to be sold in India. 13

When did the guidelines on similar biologics change?

There have also been some key changes in regulations relating to Similar Biologics. On August 16, 2016, the MoH released a new Guidelines on Similar Biologics. The change to the Guidelines on Similar Biologics, 2012 seems to have been initiated in light of a suit filed in Delhi High Court by Roche against Biocon, Mylan, and the DCGI. 14 Roche challenged the approval process followed during the grant of approvals for the biosimilar of Herceptin, alleging it was not in accordance with the process laid down in the Guidelines on Similar Biologics, 2012. Roche sought injunctions against Biocon and Mylan on account of imminent threat and credible apprehension of the introduction of the purported biosimilar version of the drug Trastuzumab.

What is the UCPMP?

One of the noteworthy pieces of legislation that the Department of Pharmaceuticals (DoP) is spearheading is the Uniform Code of Pharmaceutical Marketing Practices (UCPMP). UCPMP was implemented effective January 1, 2015 as a voluntary code. The Code has provisions on gifts, hospitality, and travel that the industry allegedly extends to doctors as well as provisions on claims and comparisons, textual and audio-visual promotional material, and the conduct of sales representatives and the samples they provide to doctors. The Department is now proposing to make UCPMP statutory and mandatory under the Essential Commodities Act, 1955 along with penal provisions for companies violating the Code.

What is the NPP draft?

The current draft NPP proposes to put a restraint on multiple brand names and implement the principle of one manufacturer, one salt, one brand name, and one price. In addition, the draft NPP proposes to prohibit third-party manufacturing that companies use for brand variation of the same formulation.

What is the issue of the sale of the same drug under different brand names and different prices?

It was recommended that a separate committee be constitu ted to suggest measures to prevent the misuse of current practice with respect to third-party manufacturing of drugs wherein a product manufactured by a single company is marketed by multiple companies. The current draft NPP proposes to put a restraint on multiple brand names and implement the principle of one manufacturer, one salt, one brand name, and one price. In addition, the draft NPP proposes to prohibit third-party manufacturing that companies use for brand variation of the same formulation.

How many technical persons are required for pharmaceutical manufacturing?

Qualification and eligibility of technical person may vary according to countries. Generally minimum of two technical persons is required by a pharmaceutical manufacturing unit for efficient running and following GMP norms.

What is pharmaceutical manufacturing?

Pharmaceutical manufacturing means a set of operations that includes purchasing of raw material, processing, production, packaging, releasing, storage and shipment of medicines and pharmaceutical products in accordance with good manufacturing practice.

What is the first part of a pharmaceutical manufacturing unit?

First part is to set-up of plant and basic requirement for manufacturing unit. A Pharmaceutical manufacturing unit should compile with two regulations: Listen to Post. Factory Act regulations.

What is the minimum area required for ophthalmic preparation?

Fully air locked, sterile and non contaminated area is required for ophthalmic preparations. Minimum area require for ophthalmic section is twenty five square meters and ancillary area is ten square meters. Parenteral section like ampoules and vials for injections etc are of two types.

How many square meters are required for a capsule section?

If coating section is required then it should be separate from other section having minimum of thirty square meters area for basic installation and ten square meters for ancillary area. Capsule section requires minimum of twenty five square meters area for basic installation and ten square meters for ancillary.

Do you need a distribution license for medicines?

In many countries you also require to take distribution license for distributing medicines with manufacturing license. In India, you require to take wholesale and distribution license for medicines also along with manufacturing license to distribute and sell finished good to marketing companies and distributors.

Who is Ajay Kamboj?

By Ajay Kamboj. He is Pharma Entrepreneur having a Ayurvedic Start-up. He loves to share his experience and knowledge what he acquire during his professional life. He is full time blogger, part time entrepreneur and partial time helper for new start-up's.