Note of Interactive session of NPPA and Pharma Industry & implementation of various provisions of DPCO, 2013- reg.

Date : 29.11.2013 Time : 11 am to 4.30 pm Venue: NDIM Tugalkabad Institution Area, Delhi Present : 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Mr. C.P. Singh Chairman NPPA Mr. Bansal- Organiser NDIM Mr. B K Singh- Director, Deptt of Pharmaceuticals Mr. S V Virmani India Laboratories Mr. P. K. Gupta- President CIPI, Belco Owner Mr. Waghlu- from FICCI , Director Lupin Mr. Sirish Goge- OPPI, Director Govt Affairs Mr. D.G. shah, Secretary General IPA Mr. V. Jagotse President All India Drugs Association Representatives from Industry : i) Mr. Shan-Wockhardt ii) Mr. N. Bagga- WPPL iii) Mr. Ashwani-Pharma Solutions iv) Mr. Shastri- Win bio Products v) Mr. Vivek- Indus Pharma vi) Mr. Mohan- Kerala Chemists Association vii) Mr. Naveen Sharma- Baxter viii) Ms Amita- Glenmark ix) Mr. Kumar- Dr Reddy x) Mr. Gautam- Panacea Biotech xi) Mr. Satish Arora- Ranbaxy xii) Mr. Manish - IMA

Many others from Natco- Oncology Division Hyderabad, Jubiliant life sciences etc. There were about 100 delegates. Minutes : 1. Mr. C.P. Singh briefed about DPCO 2013 & its highlights along with present scenario 2. Mr. SV Virmani Highlighted issues of a. Clubbing of Non Ceiling Prices with Ceiling Prices b. Ceiling Prices of Generics vs Branded c. Ceiling prices of Specialized Dosage Forms

3.

4.

5.

6.

d. Validity of Old DPCO e. Ceiling Price & Dollar Prices f. Margin to Retailers 16% or 20% g. 45 days implementation Time h. Inclusion of B. Nos. in Form V List Mr. P.K. Gupas Issuses a. Inadequate Infrastructure facilities to Pharma Industry by Govt. b. Exemptions of SSI industry withdrawal c. 45 days Time Frame d. 6 months advance Intimation for stopping Mfg. e. Banning of Pharma Products in above case f. Form V for Manufacturers/ Sellers g. Affidavits filed at court by 35 industries out of 2000 intimated h. Educate Industry, i. NPPA should conduct Workshops across Country Mr. Wakhlus Issues: a. Do we need NPPA? b. Allopathic Drugs users only 40% c. No control over Hospitals, Dr., other Healthcare Bills d. No capping over Food e. Overcharged amounts should float back to consumers/ patients f. Pharma Industry is in ICU g. We have 200 USFDA approved plants in India growing @ 15% h. Expenses on New Drug Costs 30 million Dollars & time frame is 10-15 years i. Pharma Industry is 2000 Cr. In India. We are 3rd largest manufacturer with every 7th person taking medicine of India. Question raised a. Overcharging issues b. Margin issues c. 1% Market shares d. 1 ml IV Fluid Ceiling Prices e. Form 1 for Scheduled or non scheduled f. PTR & MRP issues g. Data anomalies D.G. Shahs issues- Impact assessment a. China funding 80% of expenses of healthcare b. Enlarged span of Control c. Deeper Price cuts than expected d. Trade margins e. Retrospective Price changes f. Future availability of Pharmaceuticals is at Stake g. Consider cost @ benefits , Example: Liposomal techniques- Amphotericin B 5 times doses

7. 8.

9. 10.

h. Generic vs branded costs- problems for Industry i. 20% Margins wiped out from Pharma Industry j. Pharma Trades lost 4% Margins k. Govt. should reconsider 16% Margin l. Recall & relabeling issues m. Goal not achieved Mr. C.P Singh Chairman replied & clarified for various queries & issues in light manner amicably. Mr. Sirish Gogle- Highlighted similar issues followed by Mr. Narayanan, who highlighted the case of : a. Ceiling price of Injectables b. 6 lac retailers c. Distribution of Form V Price List d. Intimation when Ceiling Prices are changed 1st Time Mr. Jagotse on behalf of Mr. Shinde- Similar issues & provision of Wholesale Margins in the policy. Presentation by Mr. C. K. Arora on Soft Skills

Overall View : There are problems in implementation of DPCO 2013 order. NPPA trying its best efforts. Largely not welcomed by Pharma Industry. Industry specially Traders are annoyed with Government with wiping out of margins & imposing more & more restrictions. It was warm welcome & well organized interaction of Govt. officials & Industry people on platform provided by Mr. Bansal, NDIM, Tugalkabad Institution Area, Delhi.

N. Bagga