Lok Sabha Question No. 3161 (UNSTARRED), answered on 2017-03-21
Subject: Manufacturing of Essential Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: P. C. MOHAN, LAXMAN GILUWA

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

## LOK SABHA

## UNSTARRED QUESTION NO. 3161

## TO BE ANSWERED ON 21 st  March, 2017

## Manufacturing of Essential Drugs

## 3161.  SHRI P.C. MOHAN:

## SHRI LAXMAN GILUWA:

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

- (a) whether the Ministry has given any  guidelines  regarding  the  discontinuation  of  the medicines  manufactured  by  the  Pharma  companies  by  the  National  Pharmaceutical Pricing  Authority  especially  the  essential  drug  manufacturers,  if  so,  the  details thereof;
- (b) whether  the  Government  has  any  specific  proposal  to  formulate  guidelines  for uninterrupted supply of essential drugs in the interest of the general public; and
- (c) the details of pharma  companies producing essential drugs in Karnataka along with the discontinuance of such production, 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): Yes, Madam. Para 21(2) of Drugs (Prices Control) Order, 2013 (DPCO, 2013) lays down the provisions for discontinuation of scheduled formulations {medicines specified in the National List of Essential Medicines (NLEM) and incorporated in Schedule I of DPCO, 2013}. National Pharmaceutical Pricing Authority (NPPA) has issued  guidelines regarding discontinuation of such medicines.  The guidelines have been uploaded on the website of the NPPA i.e. www.nppaindia.nic.in/.
- (b): The  provisions  laid  down  in  Para  3  and  Para  21  (1)  of  DPCO,  2013  provide  for measures for ensuring uninterrupted supply of essential medicines.
- (c): NPPA  does  not  maintain  state-wise  list  of  pharmaceutical  companies  producing essential  drugs.  NPPA  in  collaboration  with  the  National  Informatics  Centre  (NIC)  has developed  Integrated  Pharmaceutical  Database  Management  System  (IPDMS)  or  Pharma Data  Bank  for  capturing  data  on  production,  prices  and  sales  of  pharmaceutical  products through the mandatory forms of the DPCO, 2013. As per this data, pharma companies have approximately 67 manufacturing units in the state of Karnataka.

A  statement  showing  names  of  companies  in  Karnataka  which  have  discontinued production  of  scheduled  medicines  after  obtaining  the  requisite  approval  from  NPPA  is attached as Annexure - 1.

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| Annexure - 1: List of Companies in Karnataka which discontinued production of scheduled formualtions as per Para 21 (2) of DPCO 2013   | Annexure - 1: List of Companies in Karnataka which discontinued production of scheduled formualtions as per Para 21 (2) of DPCO 2013   | Annexure - 1: List of Companies in Karnataka which discontinued production of scheduled formualtions as per Para 21 (2) of DPCO 2013   | Annexure - 1: List of Companies in Karnataka which discontinued production of scheduled formualtions as per Para 21 (2) of DPCO 2013   | Annexure - 1: List of Companies in Karnataka which discontinued production of scheduled formualtions as per Para 21 (2) of DPCO 2013   |
|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| S.                                                                                                                                     | Company Name                                                                                                                           |                                                                                                                                        |                                                                                                                                        |                                                                                                                                        |
| No. 1                                                                                                                                  | M/s Cipla Limited                                                                                                                      | Address of the company Virgonagar, Industrial                                                                                          | Name of Scheduled Medicine Atenolol 100mg tablet                                                                                       | Brand / Dosage 1. Hoipress 100 tablet                                                                                                  |
|                                                                                                                                        |                                                                                                                                        | Madras Road, Bangalore                                                                                                                 | Nifedipin 20 mg                                                                                                                        | 2. Nifelat retard tablet                                                                                                               |
|                                                                                                                                        |                                                                                                                                        |                                                                                                                                        | Diazepam 5mg tablet                                                                                                                    | 3. Zepose tablet                                                                                                                       |
|                                                                                                                                        |                                                                                                                                        |                                                                                                                                        | Hyoscine Butylbromide 10mg tablet                                                                                                      | 4. Hyospan tablet                                                                                                                      |
| 2                                                                                                                                      | M/s Torrent Pharmaceuticals                                                                                                            | 11& 16, 5th Floor, Vayudooth Chambers, Trinity Circle, MG Road, Bangalore, Karnataka, Bangalore - 560001.                              | Amiodrarone 50 mg Injection                                                                                                            | 1.Ritebeat Inj. 3ml,                                                                                                                   |
|                                                                                                                                        |                                                                                                                                        |                                                                                                                                        | Isosorbide-5 Mononitrate 10 mg tablet                                                                                                  | 2.Vasotrate 10mg 10's,                                                                                                                 |
|                                                                                                                                        |                                                                                                                                        |                                                                                                                                        | Isosorbide-5 Mononitrate 20 mg tablet                                                                                                  | 3. Vasotrate 20mg 10's,                                                                                                                |
|                                                                                                                                        |                                                                                                                                        |                                                                                                                                        | Fluconazole 100 mg capsule                                                                                                             | 4.Syscan 100 cap 4's                                                                                                                   |
|                                                                                                                                        |                                                                                                                                        |                                                                                                                                        | Ciprofloxacin 250 mg tablet                                                                                                            | 5. Quintor 250mg                                                                                                                       |
| 3                                                                                                                                      | M/s Astrazeneca                                                                                                                        | 12th Mile Bellary Road, Kottigenahalli Village, Yelahanka, Bangalore                                                                   | Gefitinib 250 mg tablet (10's Pack)                                                                                                    | (IressaTM)                                                                                                                             |

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