Lok Sabha Question No. 2101 (UNSTARRED), answered on 2018-07-31
Subject: Trade of Generic Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: SANKAR PRASAD DATTA

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION No. 2101 TO BE ANSWERED ON THE 31 st  July, 2018

## Trade of Generic Medicines

2101. SHRI SANKAR PRASAD DATTA:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) the details of India's share in the global trade of generic pharmaceuticals;
- (b) the total quantity and value of production of generic pharmaceuticals along with the quantity and value of such products exported and imported during the last three years and the current year, category-wise;
- (c) the share of generic and non-generic medicines to the total sales of medicines in the country including in the Government hospitals; and
- (d)  the  steps  taken/being  taken  by  the  Government  to  promote  the  use  of  generic medicines and the outcome of such steps, if any?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY  OF  SHIPPING  AND  MINISTRY  OF  CHEMICALS  AND  FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

- (a): As per the information received from Department of Commerce, total global generic market was estimated to be around USD 302 bn in 2017 and India's export of generic pharmaceuticals  during  the  same  period  is  USD  12.90  bn  (Drug  Formulations  & Biologicals).
- (b): Information about production of generic pharmaceuticals is not available. However, the export and import figures of Drugs, Pharmaceuticals and allied products for the last 3 years and current year is as under:

| India's Pharma Exports $ million   | India's Pharma Exports $ million   | India's Pharma Exports $ million   | India's Pharma Exports $ million   |                    |
|------------------------------------|------------------------------------|------------------------------------|------------------------------------|--------------------|
| Category                           | 2015-16                            | 2016-17                            | 2017-18                            | 2018-19 Up to June |
| AYUSH                              | 111.18                             | 123.67                             | 144.36                             | 34.46              |
| BULK DRUGS AND DRUG INTERMEDIATES  | 3597.28                            | 3383.52                            | 3539.38                            | 932.78             |
| DRUG FORMULATIONS AND BIOLOGICALS  | 12647.84                           | 12666.44                           | 12908.76                           | 3375.43            |
| Herbal Products                    | 252.81                             | 278.02                             | 311.50                             | 84.38              |
| SURGICALS                          | 302.90                             | 333.36                             | 371.81                             | 141.44             |
| Grand Total                        | 16912.01                           | 16785.00                           | 17275.80                           | 4568.49            |

| India's Pharma exports By quantities in Kgs   | India's Pharma exports By quantities in Kgs   | India's Pharma exports By quantities in Kgs   | India's Pharma exports By quantities in Kgs   | India's Pharma exports By quantities in Kgs   |
|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Caegory                                       | 2015-16                                       | 2016-17                                       | 2017-18                                       | April-May 2018                                |
| AYUSH AND HERBAL PRODUCTS                     | 95874113                                      | 83357976                                      | 89844622                                      | 169501198                                     |
| BULK DRUGS, DRUG INTERMEDIATES                | 351383457                                     | 327154301                                     | 345313090                                     | 60944828                                      |
| DRUG FORMULATIONS, BIOLOGICALS                | 375083930                                     | 352117517                                     | 320290646                                     | 50904284                                      |
| Grand Total                                   | 822341500                                     | 762629794                                     | 755448358                                     | 128799310                                     |

| India's Pharmaceutical imports   | India's Pharmaceutical imports   | India's Pharmaceutical imports   | India's Pharmaceutical imports   | India's Pharmaceutical imports   | India's Pharmaceutical imports   | India's Pharmaceutical imports   |
|----------------------------------|----------------------------------|----------------------------------|----------------------------------|----------------------------------|----------------------------------|----------------------------------|
|                                  | 2015-16                          | 2015-16                          | 2016-17                          | 2016-17                          | 2017-18                          | 2017-18                          |
| Description                      | Value $ Mn                       | Qty Kgs                          | Value $ Mn                       | Qty Kgs                          | Value $ Mn                       | Qty Kgs                          |
| AYUSH AND HERBAL PRODUCTS        | 54.13                            | 11668422                         | 53.50                            | 11668422                         | 60.92                            | 13625853                         |
| BULK DRUGS, DRUG INTERMEDIATES   | 3214.17                          | 268437081                        | 2712.88                          | 268437081                        | 2993.26                          | 310002111                        |
| DRUG FORMULATIONS, BIOLOGICALS   | 1334.24                          | 2969745                          | 1444.87                          | 2969745                          | 1840.78                          | 9142244                          |
| SURGICALS                        | 571.90                           | 735212051                        | 553.47                           | 735212051                        | 585.73                           | -                                |
| Grand Total                      | 5174.44                          | 1018287299                       | 4764.71                          | 1018287299                       | 5480.69                          | 332770208                        |

(c): The specific share of generic (branded as well as unbranded) and non-generic medicines to the total  sales  of  medicines  in  the  country  including  in  the  Government hospitals is not maintained in the Department. However, 98%of the medicines sold in India are off-patent (patent expired) and therefore generic medicines only.

(d): The Government is taking various steps to promote the use of generic medicines in the country.

Directions were issued to doctors for prescribing low-cost  generic drugs to the patients. The details are as follows:

- (i) Ministry  of  Health  &  Family  Welfare  vide  their  Circular  dated  08.04.2015  has directed all the specialists/doctors working in CGHS to ensure that generic drugs are  prescribed  to  the  maximum  extent  possible  with  a  view  to  make  medical treatment cost effective and affordable.
- (ii) The  Medical Council of India has amended  the  Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 on 08.10.2016 to provide a new para 1.5 : 'Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs.'
- (iii) Director, CGHS  has  vide Office Memorandum  dated  08.09.2017, issued instructions to all CGHS Wellness Centres to ensure that prescription is only by generic name wherever generic drugs are available.

In  order  to  make  generic  medicines  more  accessible,  the  Department  of Pharmaceuticals has requested all the States/Union Territories to explore and enforce the proposal of keeping a separate shelf/rack for generic medicines in every pharmacy in the country. Further, Government is successfully operating a scheme in the name of 'Pradhan Mantri  Bhartiya  Janaushadhi  Pariyojana'  (PMBJP)  for  providing  quality,  unbranded generic medicines at affordable prices in the country. As on 26.07.2018, 3883 PMBJP Kendras are functional in 34 States/Union Territories of the country.

With these measures, the use of unbranded generics is on the increase in the country and it is now estimated at 7% of the domestic market share.

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