Lok Sabha Question No. 3347 (UNSTARRED), answered on 2015-12-18
Subject: Generic Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: BHANU PRATAP SINGH VERMA, RAVINDRA KUMAR PANDEY, RODMAL NAGAR, K. MARAGATHAM, RADHESHYAM BISWAS

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO.3347 TO BE ANSWERED ON 18 TH DECEMBER, 2015

## GENERIC DRUGS

## 3347. SHRI BHANU PRATAP SINGH VERMA:

SHRI RAVINDRA KUMAR PANDEY:

SHRI NAGAR RODMAL:

SHRIMATI K. MARAGATHAM:

SHRI RADHESHYAM BISWAS:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether the Government has drawn any action plan to promote and improve access to the generic drugs to boost healthcare services in the country;
- (b) if so, the details thereof indicating the financial and operational modalities worked out for the purpose, State/UT - wise;
- (c) the measures taken/proposed to be taken by the Government to impress upon the doctors in cluding those working under the Central Government Health Scheme (CGHS) and in private healthcare facilities to prescribe generic drugs; and
- (d) the other steps being taken by the Government to ensure the quality, safety and standards of the generic drugs in the country?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI JAGAT PRAKASH NADDA)

- (a) & (b): Public  Health  being  a  state  subject,  the  primary  responsibility  of  prov improved access to generic drugs lies with the State/UT governments. Unde r the National Health Mission (NHM), financial support is provided to the States/UTs for strengthening healthcare delivery system including support for provision of free generic drugs to th access  public  health  facilities  based  on  the  requirem ent  posed  by  the  States/UTs  in  their Programme  Implementation  Plans.  An  incentive  of  upto  5%  additional  funding  under  th NHM  is  provided  to  those  states  that  introduce  free  generic/essential  drugs.  Furth central  government  has  launched  the  Jan  Aush adhi  Scheme  to  make  available  generic medicines at affordable pric es to all through Jan Aushadhi Stores (JAS). The Governmen developed  and  issued  operational  guidelines  for  Free  Drugs  Service  Initiative  to  p guidance to the States

The details of Approvals & Expenditure for Procurement of Drugs under NHM for the FY 2015- 16 is at Annexure.

(c): A  number  of  steps  have  been  taken  by  the  Government  to  promote  use  of  generic medicines.  Circulars/  instructions  have  been  issued  from  time  to  time  to all  Central Government hospitals, CGHS dispensaries and State Governments for encouraging prescription of generic medicines. Besides, the Code of Medical Ethics under Indian Me Council Regulations, 2002 also mandates prescription of drugs with generic names.

(d): The steps taken by the Government to check Spurious/Sub - Standard Drugs including generic in the country include:

- I. amending the Drugs and Cosmetics Act, 1940 by the Drugs & Cosmetics (Amendment) Act, 2008 to provide for more stringent penalties for manufacture a trade of spurious and adulterated drugs.
- II. m aking provisions in the Drugs & Cosmetics (Amendment) Act, 2008 for setting up o Special  designated  courts  for  speedy  d isposal  of  cases  to  deal  with  the  cases  of offences under the Drugs and Cosmetics Act.
- III. issuance of  guidelines for taking action on samples of drugs declared spurious of standard quality in the light of enhanced penalties under the Drugs & Cosme s (Amendment)  Act,  2008  on  the  Website  of  CDSCO  for  purpose  of  uniform implementation of Drugs and Cosmetics Act in the Country.
- IV. i nitiation of Whistle Blower Scheme to encourage vigilant Public Parti cipation in the dir ection of Movement of spurious drugs in the country.
- V. providing  assistance  for  upgrading  of  testing  facilities  and  establishing  new testing laboratories under the Capacity Building project through Wold Bank, so a enhance the capacity of the laboratories to test large number of sample s.
- VI. overseas  inspection  of  drug  manufacturing  sites  to  ensure  quality  of  imported drugs.
- VII. amendment  of  Schedule M to  the  Drugs  and  Cosmetics  Rules,  1945,  pertaining  to Good  Manufacturing  Practices  in  2001  to  make  it  at  par  with  the  internatio stand ards. It is mandatory for the manufacturers of drugs to comply with requirem of this schedule for quality control of the drugs manufactured by them.
- VIII. Introduction of Good laboratory Practices .

## Annexure

## Statement showing the Approvals & Expenditure of funds for the Head Procurement of Drugs under NHM during the F.Y. 2015 -16

(Rs. In Crore)

| Sl. No.   | Activity             | Child Health (JSSK) - Drugs & Consumables   | Child Health (JSSK) - Drugs & Consumables   | Maternal Health (JSSK) -Drugs & Consumables   | Maternal Health (JSSK) -Drugs & Consumables   | Procurement of Drugs and supplies   | Procurement of Drugs and supplies   |
|-----------|----------------------|---------------------------------------------|---------------------------------------------|-----------------------------------------------|-----------------------------------------------|-------------------------------------|-------------------------------------|
|           |                      | SPIP Approvals                              | Exp.                                        | SPIP Approvals                                | Exp.                                          | SPIP Approvals                      |                                     |
| 1         | Bihar                | 3.07                                        | 0.36                                        | 34.44                                         | 3.47                                          | 130.71                              | 7.33                                |
| 2         | Chattisgarh          | 1.63                                        | 0.10                                        | 10.18                                         | 1.73                                          | 49.74                               | 0.01                                |
| 3         | Himachal Pradesh     | 0.50                                        | 0.80                                        | 3.88                                          | 3.38                                          | 26.47                               | 10.92                               |
| 4         | Jammu & Kashmir      | 0.68                                        | 1.38                                        | 11.87                                         | 11.62                                         | 3.71                                | 0.07                                |
| 5         | Jharkhand            | 1.62                                        | 0.31                                        | 20.33                                         | 5.50                                          | 29.17                               | 2.13                                |
| 6         | Madhya Pradesh       | 1.00                                        | 0.09                                        | 31.54                                         | 11.49                                         | 91.73                               | 34.32                               |
| 7         | Orissa               | 1.04                                        | 0.07                                        | 2.15                                          | 0.58                                          | 5.13                                | 1.46                                |
| 8         | Rajasthan            | 3.20                                        | 0.22                                        | 46.19                                         | 3.67                                          | 130.20                              | 8.71                                |
| 9         | Uttar Pradesh        | 0.00                                        | 0.13                                        | 127.00                                        | 15.59                                         | 153.00                              | 18.35                               |
| 10        | Uttarakhand          | 0.94                                        | 0.01                                        | 4.40                                          | 0.79                                          | 19.48                               | 1.35                                |
| 11        | Arunachal Pradesh    | 0.01                                        | 0.00                                        | 0.87                                          | 0.29                                          | 5.09                                | 0.12                                |
| 12        | Assam                | 1.20                                        | 0.04                                        | 15.60                                         | 0.27                                          | 89.18                               | 63.95                               |
| 13        | Manipur              | 0.07                                        | 0.08                                        | 1.62                                          | 0.78                                          | 1.57                                | 0.29                                |
| 14        | Meghalaya            | 0.18                                        | 0.01                                        | 1.26                                          | 0.09                                          | 3.65                                | 0.00                                |
| 15        | Mizoram              | 0.06                                        | 0.01                                        | 0.98                                          | 0.10                                          | 2.31                                | 1.42                                |
| 16        | Nagaland             | 0.06                                        | 0.00                                        | 0.93                                          | 0.00                                          | 2.77                                | 1.97                                |
| 17        | Sikkim               | 0.03                                        | 0.01                                        | 0.45                                          | 0.24                                          | 3.09                                | 0.37                                |
| 18        | Tripura              | 0.14                                        | 0.06                                        | 2.55                                          | 0.43                                          | 9.91                                | 0.66                                |
| 19        | Andhra Pradesh       | 0.54                                        | 0.00                                        | 16.48                                         | 1.96                                          | 29.26                               | 0.00                                |
| 20        | Goa                  | 0.07                                        | 0.01                                        | 0.45                                          | 0.01                                          | 2.20                                | 0.10                                |
| 21        | Gujarat              | 1.92                                        | 0.93                                        | 24.84                                         | 4.70                                          | 50.84                               | 3.12                                |
| 22        | Haryana              | 0.00                                        | 0.03                                        | 3.69                                          | 0.96                                          | 17.15                               | 0.68                                |
| 23        | Karnataka            | 1.80                                        | 0.20                                        | 36.00                                         | 8.03                                          | 29.66                               | 0.92                                |
| 24        | Kerala               | 0.45                                        | 0.08                                        | 8.97                                          | 2.04                                          | 4.93                                | 0.00                                |
| 25        | Maharashtra          | 0.84                                        | 0.00                                        | 56.04                                         | 2.04                                          | 296.14                              | 39.17                               |
| 26        | Punjab               | 0.85                                        | 0.01                                        | 13.72                                         | 0.69                                          | 61.31                               | 32.87                               |
| 27        | Tamil Nadu           | 1.80                                        | 0.04                                        | 44.70                                         | 0.61                                          | 66.06                               | 58.50                               |
| 28        | Telangana            | 0.00                                        | 0.00                                        | 14.70                                         | 0.85                                          | 20.80                               | 0.00                                |
| 29        | West Bengal          | 2.28                                        | 7.63                                        | 54.52                                         | 21.34                                         | 24.74                               | 12.96                               |
| 30        | A & N Islands        | 0.01                                        | 0.00                                        | 0.05                                          | 0.00                                          | 0.20                                | 0.00                                |
| 31        | Chandigarh           | 0.00                                        | 0.00                                        | 1.63                                          | 0.00                                          | 0.00                                | 0.00                                |
| 32        | Dadra & Nagar Haveli | 0.02                                        | 0.00                                        | 0.24                                          | 0.00                                          | 0.65                                | 0.00                                |
| 33        | Daman & Diu          | 0.01                                        | 0.00                                        | 0.06                                          | 0.00                                          | 0.15                                | 0.05                                |
| 34        | Delhi                | 0.09                                        | 0.00                                        | 2.40                                          | 0.16                                          | 0.00                                | 0.00                                |
| 35        | Lakshadweep          | 0.05                                        | 0.00                                        | 0.05                                          | 0.00                                          | 0.36                                | 0.00                                |
| 36        | Puducherry           | 0.09                                        | 0.00                                        | 1.52                                          | 0.23                                          | 1.34                                | 0.48                                |
|           | Total                | 26.24                                       | 12.59                                       | 596.29                                        | 103.65                                        | 1362.67                             | 302.29                              |

## Note:

- 1) Figures of Expenditure are as per FMR,

hence provisional.

- 2) Expenditure is inclusive of previous years unspent balance.
- 3) SPIP and Exp. stands for State Programme Implementation Plan  and Expenditure.