Overnight ban on Fixed Dose Combination Drugs by

Government of India: Impacts & Analysis on Indian

Pharmaceutical Industry

Dissertation ReportMentor: Submitted by:Dr. Shibu John Akshay SaxenaHead of Department Pharma MBA-4th SemJamia Hamdard Jamia Hamdard

Objectives1. Reason for ban on FDC drugs2. Financial loss endured by the pharma companies3. Measures taken by the pharma companies4. Impact on consumers

Research Methodology• Research DesignAn observational study was done on the recent ban on over 300 drugs to study its implications on the pharmaceutical market in India.• Research ToolsA checklist was prepared keeping in view of the objectives. The data was collected from the secondary sources. • Data CollectionThe data was collected from secondary resources such as few published journals, newspaper articles, websites, case studies and online organizational records.Primary data was collected by interviewing five chemists in West Delhi.

The Ban• On 10 March 2016, the Union Health Ministry banned 344

fixed drug combinations by issuing a gazette notification.

• Fixed dose combination (FDC) drugs including analgesics, anti-diabetic, respiratory and gastro-intestinal medicines.

• The list is inclusive of a number of commonly used cough syrup solutions, as well as antibiotic combinations.

Cont..• What is a fixed-dose combination?oIt refers to a product that contains two or more active

ingredients.

oBecause the product is of a defined composition, the two (or more) ingredients are present in a fixed ratio. Hence the term “fixed dose” or “fixed ratio” combination.

Cont..FDC Drugs in Indian Law• Appendix VI of Schedule Y specifies the requirements for

approval for marketing of various types of FDCs.• The principal notification under Section 26-A of the Drugs and

Cosmetics Act, 1940, (prohibiting manufacture, sale and distribution of certain FDCs, which do not have any therapeutic justification or are likely to involve risk to the human being).• Banned 79-drug formulations from the year 1983 till date.

Including anti-inflammatory agents and tranquillizers, of anti-histamines with anti-diarrheal.

list of companies and their products that are affected

Reason for the ban of FDC drugs

• The CDSCO gave three main reasons for the ban: the drugs were:

1. “likely to involve risk to human beings” 2. “there are safer alternatives available in the market.” 3. “found to have no therapeutic justification”

Type of FDCs Banned

Major side effects caused by banned drugs

Financial Loss

Drop in Shares

Cont..• The annual impact of the ban, according to AIOCD (All

Indian Origin Chemists & Druggist) and Pharmasofttech AWACS (Airborne Warning And Control System) — a pharmaceutical market research firm, is estimated to be Rs 3,049 crore, affecting 3% of the retail pharma market.

Measures Taken by Pharma Industries

• Many of these drugs are cleared or licensed officially by the state licensing authorities under the Drugs and Cosmetics Act and also by the office of the DCGI. • Further, these medicines are prescribed to the patients by

thousands of qualified doctors, and no adverse reaction has been reported either of efficacy or of safety.• The drug companies said the ban has taken them by

surprise as they were not informed and consulted by the government before issuing the notification March 10.

Cont..• The drugs that have been banned in India are likely to be

diverted to African countries or even SAARC countries except Pakistan and Afghanistan, as the Central government has not banned their exports.• Procter & Gamble, Abbott India, Macleods Pharma,

Embiotic Laboratories, Juggat Pharma Anglo French, Ce Chem and Pfizer Limited moved to Delhi HC & have been granted stay on the ban.

Impact of ban on consumers

• Mostly OTC drugs

• Many banned drugs were available but will be given only on two conditions:

1. The customer must show the prescription and2. The chemist shop will issue a bill

Conclusion• Ban was shocking to all pharma companies as the reason

given by the CDSCO was not solid enough.• No notice period was given to the companies before the ban

• All the inventory had to be either destroyed or exported.• Despite of ban, these FDCs were available to the customers.• This ban should have taken 10-12 years ago if it is now found

to have “no therapeutic justification”.

Thank You