How to get Pollution Board License for medicines and pharmaceuticals manufacturing?

Introduction

India is the world's top supplier of generic drugs. The Indian pharmaceutical industry supplies more than half of world demand for vaccines, 40% of generic demand in the United States, and 25% of all pharmaceuticals in the United Kingdom. India is the world's third-largest producer of pharmaceuticals by volume and the fourteenth-largest producer by value. A network of 3,000 drug companies and 10,500 manufacturing units makes up the domestic pharmaceutical sector.

India is a major player in the global pharmaceutical sector. Furthermore, the country has a large pool of scientists and engineers with the ability to boost the industry to new heights. Indian pharmaceutical companies currently supply over 80% of the antiretroviral medications needed to combat AIDS (Acquired Immune Deficiency Syndrome) around the world.

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Market Size of Pharmaceuticals Industry

The domestic market is slated to rise thrice in the next decade, according to the Indian Economic Survey 2021. In 2021, India's domestic pharmaceutical market is expected to be worth US$ 42 billion, rising to US$ 65 billion by 2024 and US$ 120-130 billion by 2030.

Biopharmaceuticals, bio-services, bio-agriculture, bio industry and bioinformatics are all part of India's biotechnology industry. In 2019, the Indian biotechnology sector was worth US$ 64 billion, and by 2025, it is predicted to be worth US$ 150 billion.

In FY21, India's medicine and pharmaceutical exports totaled US$ 17.57 billion (From December 2020 to April 2021).

Government Initiatives

The following are some of the government's initiatives to encourage India's pharmaceutical industry:

• The Department of Pharmaceuticals launched a production-linked incentive (PLI) scheme to promote domestic manufacturing by setting up greenfield plants with minimum domestic value addition in four separate ‘Target Segments' with a cumulative outlay of Rs. 6,940 crore (US$ 951.27 million) from FY21 to FY30 to achieve self-reliance and reduce import dependency in the country's essential bulk drugs.
• The Punjab government stated in February 2021 that three pharma parks would be built in the state. A pharma park has been proposed in Bathinda, which will be stretched over 1,300 acres and cost Rs. 1,800 crore (US$ 245.58 million). Another medical park for Rs. 180 crore (US$ 24.56 million) has been proposed in Rajpura, while a greenfield project in Wazirabad, Fatehgarh Sahib, has been planned.
• The Ministry of Health and Family Welfare has been given Rs. 73,932 crore (US$ 10.35 billion) in the Union Budget 2021-22, while the Department of Health Research has been given Rs. 2,663 crore (US$ 365.68 billion). The 'National Health Mission' received a budget of Rs. 37,130 crore (US$ 5.10 billion) from the government. Over the course of six years, the PM Aatmanirbhar Swasth Bharat Yojana will receive Rs. 64,180 crore (US$ 8.80 billion). The Ministry of AYUSH has been given a budget of Rs. 2,970 crore (US$ 407.84 million), up from Rs. 2,122 crore (US$ 291.39 million) previously.

What are license and registration required for medicines and pharmaceuticals formulation units

1. Set-up legal entity-   Give an identity to your business by choosing any one of the options given below.

•  Proprietorship
• Partnership
• Private Limited Company
•  Public Limited Company
• Producer Company
• Limited Liability Partnership
• Co-operative Societies
• Trust

1. Drug Approval from CDSCO- The Drugs and Cosmetics Act of 1940 and its Rules of 1945 handed diverse tasks for drug and cosmetic regulation to central and state regulators. It aims to ensure uniform application of the Act's and Rules' provisions in order to protect patients' safety, rights, and well-being by regulating pharmaceuticals and cosmetics.  The Central Drugs Standard Control Organization (CDSCO) is responsible for approving new drugs, conducting clinical trials, establishing drug standards, monitoring the quality of drugs imported into the country, and coordinating the activities of State Drug Control Organizations by providing expert advice in order to achieve uniformity in the enforcement of the Drugs and Cosmetics Act.

1. Pollution certificate/NOC- Every business entity has the responsibility to get pollution certificate/NOC from concerned State Pollution Control Board (SPCB)/Pollution Control Committee (PCC). The following certificate comes under the purview of Pollution board in respect of above processing unit.

1. Consent to Establish- Every occupier needs to obtain Consent to Establish (CTE) for establishment of unit from concerned State Pollution Control Board (SPCB)/Pollution Control Committee (PCC). Medicines and pharmaceuticals formulations come under orange category as per standard pollution index.
2. Consent to Operate- Before operating the unit, each occupant must get a Consent to Operate (CTO) certificate. It is provided by the authority for a period ranging from one to ten years, depending on the location and category.
3. Hazardous waste Authorization - Manufacturing of Medicines and pharmaceutical formulations generate hazardous waste, as per Schedule I of Hazardous Waste Management, Rules 2016. The applicant is required to apply for Hazardous waste Authorization to the Pollution Control Board and explain the steps taken to reduce or dispose of these chemicals in an environmentally sound manner.

    What are the important documents and Information required to get Pollution Certificate/NOC                 

• Pan card and UID of Authorized Person
• Pan card of Unit
• Project Report
• Rent Agreement or Property Paper
• Layout Plan
• Udyog Aadhar/DIC certificate
• Change of land use (if unit located in agriculture area)
• ETP and STP details
• CA certificate on investment
• CGWA/State Water Regulatory  NOC
• Water usage
• Air Pollution Control Equipment Details
• DG set (if any)
• Manufacturing Process and
• MOA and AOA/Partnership deed

What are the procedure the to obtain Pollution certificate/NOC /Authorization 

• Create user id and password
• File an application through user id and password
• Payment of govt fee
• Inspection will conduct by concerned officer
• ATR preparation by department
• File sent for meeting or Regional officer or Head office as the case may be
• Approved in meeting or by Regional officer or Head office as the case may be
• Download certificate from Pollution control’s website

1.  Drug License for Manufacturing- The manufacturer needs permission from concerned drug control department to manufacture drugs. License applications can be submitted through online or offline on typed paper in the approved format.

1. DIC/SSI Registration

• Any item that does not require an industrial license, such as those mentioned in Schedule-III and those not mentioned in Schedule-I or Schedule-II of the licensing Exemption Notification, can apply for a Provisional Registration Certificate (PRC). Even for those items specified in Schedule-II, units employing less than 50/100 workers with/without power can apply for registration.

• The unit submits an application for PRC on the approved form. There is no field investigation and a PRC is issued.

• The PRC is valid for a period of five years. If the entrepreneur is unable to open the business within this time frame, he can reapply at the conclusion of the five-year period.

• The unit must apply for permanent registration on the appropriate form once it begins production.

1. No-Objection Certificate from Central Ground Water Authority (CGWA) or State Regulatory Authority

If the occupier is using ground water for his/her unit than, before harvesting ground water, every business enterprise must obtain approval from the Central Ground Water Authority or the State Ground Water Regulatory Authority. The Indian Parliament passed the Environment (Protection) Act, 1986, to control, monitor, and manage pollution, as well as to protect the environment in the Union Territory of India. Under Section 3 (3) of the Environment (Protection) Act, 1986, the Central Ground Water Authority was founded with the purpose of developing and maintaining all of India's water resources for future generations.

1. Others licenses/registrations required for drugs and pharmaceutical unit   

• Factory License
• Labor License
• Trademark
• ISO certificate
• Good Manufacturing Practices (GMP) certification

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